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1 | Timestamp | Today's date | Originating author(s) | Address | Telephone | Proposed format(s) | Target meeting or journal | Submission deadline or target completion date | Meeting date (if applicable) | Meeting location (if applicable) | Proposed Title | SDMC Data Analysis Required | Hypothesis / research question / objective 1 | Hypothesis / research question / objective 2 | Hypothesis / research question / objective 3 | Data needed for analysis | Brief explanation of data required | Data requested by | Hypothesis Writing Group (additional investigators / authors) | Comments | |||||||||||||||||||||||||
2 | 5/14/2015 9:10:14 | Lunney, Ratcliff | mlunney@emory.edu | 49 Jesse Hill Jr. Dr. SE Suite 126 Atlanta, GA 30303 | 404-778-1702 | Manuscript | unknown | 12/1/2015 | Characteristics of moderate and severe traumatic brain injury patients without abnormal findings on baseline computed tomography brain imaging. | No | Describe 125 ProTECT III subjects with no abnormalities found on baseline CT (demographics, clinical presentation, acute interventions required). | Assess and describe any additional/subsequent head imaging obtained for subjects in this sample. | Describe outcomes for sample and determine if there are prognosticators specific or clinically-relevant to TBI pts with negative baseline CTs. | Imaging | Demographics, initial presentation, radiology form, additional images. | 5/20/2015 | D. Wright, V. Hertzberg, Matt Gregory (Emory biostats intern) | In progress | |||||||||||||||||||||||||||
3 | 8/20/2015 5:21:06 | Jeremy Juern, David Milia | jjuern@mcw.edu; mmena@mcw.edu | Medical College of Wisconsin-Department of Emergency Medicine Froedtert East Hospital/Pavilion Bldg 1P 9200 W. Wisconsin Ave. Milwaukee, WI 53226 | 414-80-0195 | Manuscript | AAST (American Association for Surgery in Trauma), Journal of Trauma and Acute Care Surgery | 3/1/2016 | Hawaii | Functional outcomes of adults with traumatic brain injury who required tracheostomy and gastrostomy | No | TBI patients who required tracheostomy and gastrostomy have worse outcomes than those who did not require those two procedures. | CRF data | Demographics, procedures, mortality, level of dependence/independence, other functional outcomes | 8/20/2015 | Tom Aufderheide,Melissa Mena | |||||||||||||||||||||||||||||
4 | 7/14/2016 11:49:08 | Martin Schreiber, MD | schreibm@ohsu.edu | Oregon Health & Science University 3181 S.W. Sam Jackson Park Road Mail Code: L611 Portland, OR 97239 | 503 494-7883 | Manuscript | Journal of Trauma | Does timing of prophylactic anticoagulation affect outcomes in TBI patients | No | There is no difference in the morbidity/mortality in ProTECT-III patients based on timing of initiation of prophylactic anticoagulation? | There are significant variations in prophylactic anticoagulation practices between institutions? | CRF data, (radiology reports stating stable/improved intracranial hemorrhage versus progression of hemorrhage) | We need demographics data, as well as data for primary (functional outcome at 6 month with GOS-E score) and secondary endpoints (mortality, Disability Rating Scale, adverse event, worsening bleed on repeat CT, neurologic outcomes), timing and dosing of anticoagulation after admission, any data as to why doses were held/missed, adverse effects (especially bleeding), rates of DVT/PE | 9/12/2016 | A. Bommiasamy, C. Hilliard | ||||||||||||||||||||||||||||||
5 | 8/8/2016 14:10:18 | Rowell, Susan; Hinson, Holly; Hilliard, Cole | rowells@ohsu.edu; hinson@ohsu.edu; hilliarc@ohsu.edu | Oregon Health & Science University 3181 SW Sam Jackson Park Road Portland, OR 97239 | 503-418-2318 | Abstract, Oral Presentation, Manuscript | Western Trauma Association | 10/1/2016 | 3/5/2017 | Snowbird, UT | The association between circulating biomarkers of structural brain Injury and clinical outcome | No | To determine if initial values, or trends in serially measured circulating brain-specific biomarkers (GFAP, UCH-L1, SBDP150) are associated with the presence of ICH, injury pattern and severity of TBI. Hypothesis 1: Elevated biomarkers early after TBI more accurately predict the presence of ICH than GCS and are associated with injury severity and pattern based on the Marshall CT Classification score. | To determine if circulating brain-specific biomarkers (GFAP, UCH-L1, SBDP150) improve mortality at discharge and long-term outcome after moderate or severe acute TBI. Hypothesis 2: Biomarkers that remain elevated (or subsequently increase during the first 48 hours after injury) are associated with an increased 28-day mortality and long term function outcomes as measured by the GOS-E, DRS and mRS. | CRF data, Imaging, Biomarker | -Daily vitals -GFAP, UCH-L1, SBDP150 levels -Admission demographics -Injury type/mechanism -NIH common data elements for neuroimaging -Outcome data including GOS-E, DRS, mRS | 9/1/2016 | ||||||||||||||||||||||||||||
6 | 4/22/2015 22:02:00 | 4/22/2015 | Neal Dickert | njr@emory.edu | 1462 Clifton Road #508 Atlanta, GA 30322 | 404-712-6834 | Manuscript | Resuscitation or Academic Emergency Medicine | Understanding Relationships Between Clinical Outcome and Views of Inclusion in EFIC Research | No | Clinical outcomes do not predict whether patients and surrogates have positive or negative attitudes toward inclusion in the ProTECT III trial under EFIC. | CRF - data point locations | We need the primary clinical outcome and initial injury severity for patients included in PEER-ProTECT, for whom we have study ID numbers. | 5/30/2015 | Rebecca Pentz | David Wright | Louisa Wall | other authors of PEER-ProTECT manuscript will be invited | No | In progress | Yes | ||||||||||||||||||||||||
7 | 4/21/2015 13:42:00 | 4/21/2015 | Elizabeth Jones | elizabeth.b.jones@uth.tmc.edu | 6431 Fannin, JJL446 Houston, TX 77030 | 713-446-4786 | Post-traumatic seizures in patients in the ProTECT-III study. | Yes | Is there a difference in post-traumatic seizure rates among ProTECT-III patients treated with different prophylactic agents, or no prophylactic agent? | CRF - data point locations | demographics, GCS data, seizure prophylaxis given, adverse events. | On hold, did not have data for initial idea, but relook. In Jones court | Yes | ||||||||||||||||||||||||||||||||
8 | 3/4/2015 11:35:00 | 3/4/2015 | Jonathan Ratcliff | jratcli@emory.edu | 49 Jesse Hill Jr Drive Atlanta, GA 30303 | Manuscript | Optimization of outcomes assessment in TBI clinical trials - going beyond the glasgow outcome scale. | Despite disease heterogeneity can a parsimonious outcomes assessment be identified? | Can outcome phenotypes be identified and related to primary injury such that targeted outcomes may be performed in future trials? | CRF - data point locations | Review of outcome measures would be required. | Clarification needed | Yes | ||||||||||||||||||||||||||||||||
9 | 3/4/2015 11:27:00 | 3/4/2015 | Jonathan Ratcliff | jratcli@emory.edu | 49 Jesse Hill Jr Drive Atlanta, GA 30303 | Manuscript | Common sedation agents in the care of TBI patients and the relationship with outcome | There is no drug used more liberally in the care of the severe TBI patient than sedation yet little is known about the influence on outcome | Describe epidemiology of sedation use and relationship to vent days, ICU LOS, in hospital mortality | Secondary relationships with BP, CPP and ICP could be analyzed. | CRF - data point locations | Dont have the data | Yes | ||||||||||||||||||||||||||||||||
10 | 3/4/2015 11:21:00 | 3/4/2015 | Jonathan Ratcliff | jratcli@emory.edu | 49 Jesse Hill Jr Drive Atlanta, GA 30303 | Manuscript | When are platelets being transfused and what is the relationship with outcome? | Describe the current practice of platelet transfusion - who gets platelets | What effect does platelet transfusion have on serial neuroimaging? | Does platelet transfusion, among "at risk" patients affect outcome? | CRF - data point locations; Ancillary data need (images, biomarkers) | This would require knowledge of platelet transfusion. | Part of Transgression analysis, but only have if they required Tf. Would not have if given outside bondaries of our guidelines. Likely part of Tg paper. | Yes | |||||||||||||||||||||||||||||||
11 | 3/4/2015 11:15:00 | 3/4/2015 | Jonathan Ratcliff | jratcli@emory.edu | 49 Jesse Hill Jr Drive Atlanta, GA 30303 | Manuscript | The role of progesterone in mitigating hemorrhage expansion on serial head CTs | Progesterone is thought to regulate hemostatic proteins so does progesterone mitigate risk of hemorrhage expansion after TBI? | CRF - data point locations; Ancillary data need (images, biomarkers) | Need to look at whether we have enough CT data series to explore. Long term project | Yes | ||||||||||||||||||||||||||||||||||
12 | 3/4/2015 11:11:00 | 3/4/2015 | Jonathan Ratcliff | jratcli@emory.edu | 49 Jesse Hill Jr Drive Atlanta, GA 30303 | 4047781714 | Manuscript | Risk factors for developing coagulopathy after TBI and the role of progesterone to mitigate these effects | Coagulopathy after TBI is common yet little is known about risk factors - who becomes coagulopathic | Also, does Progesterone have any affect on mitigating TBI related coagulopathy? | CRF - data point locations; Ancillary data need (images, biomarkers) | Coagulopathy markers would be required. Imaging data may be useful as well. | Exploratory - long term project | Yes | |||||||||||||||||||||||||||||||
13 | 3/4/2015 11:02:00 | 3/4/2015 | Jonathan Ratcliff | jratcli@emory.edu | 49 Jesse Hill Jr Drive Atlanta, GA 30303 | 404778-1714 | Manuscript | The relationship between peripheral monocyte count and TBI fatality. | Monocyte counts have been observed to be associated with outcome after AIS and ICH. It is unknown if this relationship is observed in TBI as well. | CRF - data point locations | Monocyte count at admission and outcome would be required. In addition, general predictors of outcome following TBI would be necessary. | Opeolu Adeoye - Cincinnati | Lab considered data | Yes | |||||||||||||||||||||||||||||||
14 | 2/3/2015 16:12:00 | 2/3/2015 | Pratik Doshi | Pratik.b.doshi@uth.tmc.edu | University of Texas Health Science Center at Houston-Department of Emergency Medicine. 6431 Fannin St, JJL 435 Houston, TX 77030 | 8323148062 | Oral Presentation; Manuscript | Critical Care Medicine | Effect of Oxygenation and ventilation in the immediate injury period on outcomes in patients suffering from Traumatic brain injury | Yes | There is a scarcity of data regarding derangements of PaCO2 and PaO2 during the post TBI period and their association with outcome. This issue needs to be addressed as both O2 and CO2 are potent vasoactive agents regarding cerebral blood flow, with hypoxia precipitating cerebrovascular vasodilation, hypocapnea precipitating cerebrovascular vasoconstriction, and hypercapnea precipitating vasodilation as well. Given the importance of both maintenance of adequate cerebral perfusion pressure as well as control of intracranial pressure in the post TBI setting, further formal evaluation of the effect of PaCO2 and PaO2 on outcomes for patients suffering from TBI, particularly within the first 24 hours, is indicated. | Hypothesis #1: Effect of Hypoxia(defined as PO2 <60 or SaO2 <88% or P/F ratio < 300) and Hyperoxia (defined as PaO2 >300) as compared to normoxia during the immediate post injury period of 24 hours. | Hypothesis #2: Effect of Hypocapnea(defined as PaCo2 of <35) or hypercapnea(defined as PaCO2 > or = 50) as compared to normocarbia in the immediate post injusry period of 24 hours. | CRF - data point locations; Ancillary data need (images, biomarkers) | The data points needed will be any confounders that would need to be corrected for, age, sex, race, severity of illness, other injuries, location of care, presence or abscence of hypotension, etc. | Pratik Doshi | Elizabeth Jones | other interested parties welcome | Yes | Likely in Transgression paper. Will reeval post this paper, | Group with Transgression paper | Yes | |||||||||||||||||||||||
15 | 1/15/2015 13:59:00 | 1/15/2015 | Liqiong Fan | fanliq@musc.edu | 315 Queens CT APT B, Mt. Pleasant, S.C, 29464 | 8437438734 | Abstract; Oral Presentation; Manuscript | SCT, ISC, Statistics in Medicine, Stroke | The impact of covariate misclassification using generalized linear regression under covariate-adaptive randomization. | No | impact of misclassification on the estimation for the treatment effect | CRF - data point locations; Ancillary data need (images, biomarkers) | Sharon D. Yeatts | Yuko Y. Palesch | Under revision, does not need PUB review | Yes | |||||||||||||||||||||||||||||
16 | 12/16/2014 14:08:00 | 12/16/2014 | Jeremy Brown | jeremy.brown@nih.gov | 45 Center Drive Bethesda MD 20892 | 301-594-4481 | Manuscript | TBA | Withdrawing permission for study participation after enrollment via EFIC | Analysis of the LAR/subject who withdrew permission to be in the PROTECT III trial once after the patient ha already been enrolled via EFIC | Other data source | chart or enrollment notes as to more specific reason why LAR or patient withdrew permission after randomization and treatment had begun. | Wright D | No | Josh Salsman abstract similar. Let Josh know JB interested - writing up the paper. | Yes | |||||||||||||||||||||||||||||
17 | 11/20/2014 17:05:00 | 11/20/2014 | David Wright | david.wright@emory.edu | 4047781709 | Manuscript | Is ventriculostomy superior to Subarachnoid bolt for ICP monitoring in TBI | Yes | Outcomes of Bolt vs. Ventric | Adverse events of Bolt vs. Ventric | CRF - data point locations; Ancillary data need (images, biomarkers) | Bolt vs. Ventric. Decompressive Crani, mortality, GOSE Adverse events - Neuro infections/new bleeds, other relevant SAEs | Lisa Merck | Geoff Manley | other members of CST team | Yes | |||||||||||||||||||||||||||||
18 | 11/9/2014 17:40:00 | 11/9/2014 | Eric Sribnick | eric.sribnick@gmail.com | 5455 Meridian Mark Road NE Atlanta, GA 30342-1654 | 8437226736 | Manuscript | Journal of Neurotrauma | n/a | Retrospective analysis of a population of traumatic brain injury patients using the Surgical Intervention for Traumatic Injury | No | We are interested in examining placebo-treated patients to determine if the Surgical Intervention for Traumatic Injury is predictive of whether patients required surgical intervention. | Other data source | The data that we are requesting includes patient age, patient gender, whether the patient was intubated, the GCS determined in the ED, whether the patient had an enlarged pupil or not, whether the patient had a midline shift on head CT, whether the patient had pathology (e.g. blood) at the temporal lobe on head CT, and whether the patient had an epidural hematoma (and the size) on head CT. | 12/1/2014 | Poster, publication, need to reach out? | Yes | ||||||||||||||||||||||||||||
19 | 10/14/2014 12:40:00 | 10/14/2014 | Robert D. Welch | rwelch@med.wayne.edu | Department of Emergency Medicine Detroit Receiving Hospital, 6G/UHC 4201 St. Antoine, Detroit, MI 48201 | 313-993-2534 | Abstract; Manuscript | Not yet sure of target for abstract Journal Neurotrauma or Academic EM | Early Deaths and Unexpected Good Outcomes in TBI Patients - Rationale for Selecting Patients in Future TBI Studies | Yes | There are patients with TBI enrolled in clinical trials that either die very early in their hospital stay or have unexpected excellent outcomes given the degree of injury. Can we identify factors that help identify such cases and determine if such cases warrant inclusion in future therapeutic clinical trials. Actually, could be 2 hypotheses or studies. | CRF - data point locations; Ancillary data need (images, biomarkers) | Examine patients who die with 24 hours of admission, those that die 1 - 3 days from admission, and compare to those surviving longer. Will need presenting characteristics, imaging, biomarkers (if possible), and early in-hospital complications and intensive therapy (transfusion, operations, special oxygenation, pressors, etc. | 1/31/2015 | Yes | In Progress, Rob looking at Data | Yes | ||||||||||||||||||||||||||||
20 | 10/3/2014 17:14:00 | 10/3/2014 | Nina Gentile, MD | ngentile@temple.edu | Broad and Ontario Streets Temple University School of Medicine Philadelphia, PA | 215-707-8402 | Abstract; Manuscript | Favorable attitudes towards EFIC research and continued participation in ProTECTiii are mores likely in males than females and in White or Asian than Black or Hispanic respondents participating in community consultation for the use of EFIC in the ProTECTiii clinical trial. | Other data source | Responses to community consultation questions | Tamera Means | Sumaya Mekkaoui | Hannah Reimer, RN | Send to HSP working group and PUB group to review and comment. Their shop data. | Yes | ||||||||||||||||||||||||||||||
21 | 9/29/2014 19:41:00 | 9/29/2014 | Dr. John Wanebo and Lori Wood RN | Lwood@shc.org | Scottsdale Healthcare Osborn Medical Center 7400 E. Osborn Road, Scottsdale AZ 85251 | 480-882-5646 | Manuscript | Journal of Trauma | Yes | There is a modest survival and GOSE benefit for Progesterone in Caucasian, male patients with isolated moderate to severe head injury when stratified by age. | CRF - data point locations; Ancillary data need (images, biomarkers) | Dr. John Wanebo | Dr. Joseph Zabramski | Lori Wood RN | Veronica Place RN | Dr. Kurt Denninghoff | Bruce Barnhart RN | Yes | Send Database, they can review | Yes | |||||||||||||||||||||||||
22 | 9/28/2014 21:02:00 | 9/28/2014 | Chris Lewandowski | clewand1@hfhs.org | 2799 W Grand Blvd, Detroit, MI 48202 | 313-876-1552 | Manuscript | TBD | Outcomes Among TBI Patients with Normal Initial Neuroimaging. | Yes | Progesterone will demonstrate improvements in neuropsychiatric testing at 6 months. | If number of such patients is too low for above, look at detailed descriptive analysis of this cohorts outcomes, clinical characteristics and alcohol/biomarker levels | CRF - data point locations; Ancillary data need (images, biomarkers) | subjects with normal CT findings n=125 mpl 11.12.14 | Joseph Miller | ||||||||||||||||||||||||||||||
23 | 9/28/2014 20:55:00 | 9/28/2014 | Joseph Miller | jmiller6@hfhs.org | 2799 W Grand Blvd, Detroit, MI 48202 | 313-492-7381 | Manuscript | Interaction of Vitamin D Deficiency and Progesterone in the ProTECT III Trial | Yes | Vitamin D deficiency impacts the effect of progesterone on 6-month outcomes | For all study subjects, Vitamin D deficiency is associated with worse 6-month neurological outcomes in a multiregression model. | CRF - data point locations; Ancillary data need (images, biomarkers) | would require running vitamin D levels off of BioProTECT specimens | Chris Lewandowski | |||||||||||||||||||||||||||||||
24 | 9/28/2014 20:34:00 | 9/28/2014 | Joseph Miller | jmiller6@hfhs.org | 2799 W Grand Blvd, Detroit, MI 48202 | 313-492-7381 | Manuscript | TBD | Gender difference in TBI injury patterns | Yes | Female TBI patients demonstrate different patterns of brain injury than male counterparts | Female TBI patients demonstrate different systemic injury patterns (non-CNS) than their counterparts | CRF - data point locations; Ancillary data need (images, biomarkers) | Baseline CRF data, CT imaging classification, ISS details | Chris Lewandowski | ||||||||||||||||||||||||||||||
25 | 9/25/2014 17:27:00 | 9/25/2014 | M Lunney | mlunney@emory.edu | 49 Jesse Hill Jr. Dr. SE Suite 126 Atlanta, GA 30303 | 404-778-1702 | Abstract; Manuscript | Effects of progesterone on outcomes in traumatic subarachnoid hemorrhage. | Yes | 1º hypothesis: Statistically significant improvements in outcomes and reductions in mortality will be found between progesterone and placebo groups in subjects positive for SAH on baseline CT image. | 2º hypothesis: After controlling for severity of injury and other CT abnormalities, progesterone will reduce ICP and improve CPP in subjects with SAH. | Other investigations for this analysis: efficacy of progesterone in subgroups of location and severity of SAH, SAH + other CT abnormalities, isolated SAH. Correlations between location and severity of SAH and iGCS. | CRF - data point locations | Form 0, form 3, form 9, form 12, form 16, form 36, form 37. | David Wright | Lisa Merck | Jason Allen | Yes | |||||||||||||||||||||||||||
26 | 9/24/2014 17:19:00 | 9/24/2014 | Josh Salzman | joshua.g.salzman@healthpartners.com | 640 Jackson St. MS: 11109F | 651-254-5302 | Abstract; Oral Presentation; Manuscript | National Association of EMS Physicians; Prehospital Emergency Care; Potential trauma meetings (AAST, EAST - due March 2015) | 8/14/2015 | 1/14/2016 | San Diego, CA | Association between prehospital intubation and TBI outcome (control group only) | No | With standardized inhospital treatment for TBI, is prehospital intubation still associated with poor patient outcomes (death within 24 hours; died in hospital; GOSE or other neuro parameters at 6 months)? | CRF - data point locations | CRFs for patient demographics, EMS agency characteristics, ISS, enrollment GCS, pupil response, transgression proportion score (need to account for how often patients had transgressions to ensure there was a "standardized patient care protocol" | 12/1/2014 | Michelle Biros | Sandi Wewerka | Bruce Bennett | David Dries | Yes | Yes | ||||||||||||||||||||||
27 | 9/24/2014 17:10:00 | 9/24/2014 | Josh Salzman | joshua.g.salzman@healthpartners.com | 640 Jackson St. MS: 11109F | 651-254-5302 | Abstract; Oral Presentation; Manuscript | Society for Academic Emergency Medicine | 12/12/2014 | 5/12/2015 | San Diego, CA | Frequency of sedation-induced hypotension between time of injury to time of ICU admission | Yes | How frequently did this patients experience hypotension related to medication administration in the first 24 hours from time of injury? | CRF - data point locations | Patient demographics, hypovolemia transgression sheet. | 11/3/2014 | Michelle Biros | Sandi Wewerka | Bruce Bennett | David Dries | Yes | Yes | ||||||||||||||||||||||
28 | 9/24/2014 17:02:00 | 9/24/2014 | Josh Salzman | joshua.g.salzman@healthpartners.com | 640 Jackson St. MS: 11109F | 651-254-5302 | Abstract; Oral Presentation; Manuscript | Society for Academic Emergency Medicine / Academic Emergency Medicine | 12/12/2014 | 5/12/2015 | San Diego, CA | Association between Consent Decision (consent vs. decline) and Patient Prognosis | No | Hypothesis: Consent for continued participation was denied more frequently for patients with good prognosis at the time of the consent decision | Hypothesis: Consent for continued participation was denied more frequently for patients with good neurologic outcome | CRF - data point locations | All data fields from Informed Consent log, including date and time of consent or declined consent decision; patient demographic information, GOSE at 6 months | 11/3/2014 | Michelle Biros | Yes | |||||||||||||||||||||||||
29 | 9/24/2014 16:57:00 | 9/24/2014 | Josh Salzman | joshua.g.salzman@healthpartners.com | 640 Jackson St. MS:11109F St. Paul, MN 55101 | 651-254-5302 | Abstract; Oral Presentation; Manuscript | Society for Academic Emergency Medicine / Academic Emergency Medicine | 12/12/2014 | 5/12/2015 | San Diego, CA | Process Metrics for Informed Consent following enrollment under EFIC | Yes | Describe the number of consent attempts (mean/S.D or median; stratify by de-identified hub/site and patient demographic and injury characteristics) from time of injury to the time of a final decision by the family. | Describe the # hours (mean/S.D. or median; stratify by de-identified hub/site and patient demographic and injury characteristics) between time of injury to time of final decision | CRF - data point locations | All data fields from the Informed consent log; patient demographics; time of injury; time to medication start | 11/3/2014 | Michelle Biros | Yes | |||||||||||||||||||||||||
30 | 9/24/2014 12:47:00 | 9/24/2014 | Valerie Stevenson | vwillis@umich.edu | NETT CCC | 7342322141 | Abstract; Lecture; Manuscript | TBD | Cost considerations in EFIC trials/CC and PD processes | No | How do we budget CC/PD | What do we need for CC/PD | Other data source | Survey/interview data from sites involved in the CC/PD process | TBD based on interest | Yes | Yes | ||||||||||||||||||||||||||||
31 | 9/22/2014 13:36:00 | 9/22/2014 | Hannah Reimer | hreimer@temple.edu | Temple University Department of Emergency Medicine 3401 N. Broad St. Phila., PA 19140 | 2157075483 | Abstract; Manuscript | Use of One Social Network Site in Community Consultation and Public Disclosure for an Exception From Informed Consent Trial | No | Methods paper describing how social media was used in EFIC activities | Nina Gentile | Brent Freeman | Patricia McNelis | Vernon Kalugdan | No | Yes | |||||||||||||||||||||||||||||
32 | 9/17/2014 11:57:00 | 9/17/2014 | Mike Lunney | mlunney@emory.edu | 49 Jesse Hill Jr. Dr. SE Suite 126 Atlanta, GA 30303 | 404-778-1702 | Manuscript | Effects on outcome and mortality of progesterone based on CT imaging components of Rotterdam score. | Yes | 1º hypothesis: PROG will have a statistically significant effect on outcome in a subgroup analysis based on Rotterdam severity. | 2º hypothesis: PROG will have a statistically significant effect on outcome in a subgroup analysis based on component analysis (status of cisterns, midline shift, EDH, IVH/SAH). | CRF - data point locations | Form 3, form 9, form 12, form 16. | D Wright | J Allen | L Merck | No | ||||||||||||||||||||||||||||
33 | 9/17/2014 11:32:00 | 9/17/2014 | Christy Stehly | christy.stehly@sluhn.org | St. Luke's University Health Network 801 Ostrum Street Bethlehem, PA 18015 | 484-526-6076 | Abstract; Oral Presentation; Manuscript | TBD | Utilizing an on-call research assistant model to optimize enrollments in emergent treatment trials | Yes | CRF - data point locations; Other data source | Yes | |||||||||||||||||||||||||||||||||
34 | 9/16/2014 16:23:00 | 9/16/2014 | Valerie Mika | vmika@med.wayne.edu | 4201 St. Antoine UHC- 6G | 3137454350 | Abstract; Oral Presentation; Manuscript | Outcome Prediction Tools: Finding an alternative to the GCS. | Correlation of mechanism of injury, GCS and AIS injuries to GOSE and DRS. | CT images and the mechanism of injury - do they correlate to GCS | Does AIS and GCS predict d/c locations in 30 days (or number of days until discharge)? | CRF - data point locations; Ancillary data need (images, biomarkers) | The CRFs are the AIS (F11), Baseline form (F01), Eligibility (F00), Hospital discharge (F09), GOSE (F16), Disabilty Rating scale (F12). Imaging data | Yes | |||||||||||||||||||||||||||||||
35 | 5/6/2014 9:57:00 | 5/6/2014 | David W. Wright | david.wright@emory.edu | 49 Jesse Hill Jr. Drive, Atlanta GA 30303 | 404-778-1709 | Manuscript | Manuscript - NEJM | 8/1/2014 | ProTECT III: Phase III Efficacy Trial of Progesterone for the treatment of Acute Traumatic Brain Injury | Yes | Does Progesterone, administered within 4 hours of injury, improve the functional outcome (based on GOSE) of patients with acute blunt traumatic brain injury. | CRF - data point locations | Need CRF data and imaging | 5/7/2014 | Robert Silbergleit | Sharon Yeatts | Yuko Palesch | Vicki Hertzberg | Geoff Manley | Bill Barsen | Yes | Lisa H. Merck | David W. Wright | david.wright@emory.edu | same | same | ||||||||||||||||||
36 | 5/22/2014 16:57:00 | 4/29/2014 | Samir Belagaje | sbelaga@emory.edu | FOB 374 80 Jesse Hill Jr. Drive SE Atlanta, GA 30303 | 404-879-0348 | Manuscript | Neurology or J Neuro Repair | The Impact of Rehabilitation / Post Hospital Discharge Disposition on Outcomes in the ProTECT III Study | Yes | Subjects who went home or to acute Rehab had better outcomes than those who were discharged to a SNF | Was there an imbalance in the discharge disposition between 2 arms (ProgvsPlac) which could have served as a confounder | If, imbalance - did it affect overall results | CRF - data point locations | GCS initial, GCS hospital d/c, Discharge disposition, demographics | Samir Belagagi | Yes | ||||||||||||||||||||||||||||
37 | 5/22/2014 17:03:00 | 5/1/2014 | David Wright | David.wright@emory.edu | 49 Jesse Hill Jr. Drive Atlanta GA 30303 | 404-778-1709 | Manuscript | TBD | Validation of the IMPACT Prediction Model using the ProTECT III Trial | Yes | The IMPACT Prediction Model will accurately predict overall mortality and morbidity of subjects in the ProTECT III trial | Other Prediction models | CRF - data point locations | Use the IMPACT online Prediction Model and compare to the actual ProTECT III outcomes | David W. Wright | Tamara Espinoza | Geoff Manley | Lisa H. Merck | Yes | ||||||||||||||||||||||||||
38 | 5/22/2014 17:12:00 | 5/1/2013 | Kurt Denninghoff | kdenninghoff@aemrc.arizona.edu | Professor of Emergency Medicine and Optical Sciences Associate Department Head, Research The Arizona Emergency Medicine Research Center 1609 N. Warren Ave., Rm. 116 Tucson, AZ 85724-5057 | (520) 626-1551 | Manuscript | TBD | Patterns and Comparisons of EFIC vs. Non-EFIC subjects in the ProTECT III trial | Yes | Are there specific differences between the EFIC enrolled subjects vs. the Non-EFIC enrolled subject. | CRF - data point locations; Other data source | Kurt Denninghoff | David Wright | Deneil and members of HSP writing group | Yes | |||||||||||||||||||||||||||||
39 | 5/22/2014 17:31:00 | 5/2/2011 | Michelle Biros | biros001@umn.edu | Professor, Emergency Medicine Chief, Department of Emergency Medicine Hennepin County Medical Center Vice Chair of Research Department of Emergency Medicine University of Minnesota | Manuscript | Unanticipated circumstances related to implementation of an EFIC Trial | No | Explore the unanticipated circumstances around implementation of EFIC - descriptive | CRF - data point locations; Other data source | Showcase examples of several fascinating EFIC enrollment cases during the ProTECT III trial and provide Ethical commentary for each case. | Michelle Biros | David Wright | Deneil Harney | Neil Dickert | Victoria Mah | Katie Lammond | Yes | Kurt Denninghoff | Rebecca Pentz | Jill Baren | Erin Bengelink | Lisa Merck | Yes | |||||||||||||||||||||
40 | 5/23/2014 13:44:00 | 5/1/2012 | Pratik Doshi | pratik.b.doshi@uth.tmc.edu | UT Health Science Center at Houston Houston, TX | 713-500-7585 | Manuscript | The Impact of Hypothermia on patient outcomes in the ProTECT III trial | Yes | Do patients who present hypothermic have better outcomes than normothermic | Evaluation of temperature curve profile and outcome | CRF - data point locations | Based on the NABISH data, there was an improvement in patient outcomes if they were hypothermic prior to operative intervention, I would be interested in looking back on the data and breaking down the groups into patients who had an initial temperature of 35 degrees C or less, and patients that were normo-thermic, and after correcting for the demographics/ISS etc, see if the hypothesis from NABISH pans out. Additionally, I would like to see if the patients that were hypothermic to begin with, what their temperature curves look like over the first 12-24 hours and determine the effect of rewarming/rate of rewarming on outcomes. | Pratik Doshi | David W. Wright | Yes | |||||||||||||||||||||||||||||
41 | 5/23/2014 13:48:00 | 5/1/2012 | David W. Wright | david.wright@emory.edu | 49 Jesse Hill Jr. Drive Atlanta GA 30303 | 404-778-1709 | Manuscript | The Effect of temperature and temperature control on patient outcome in the ProTECT III trial | Yes | Do patients who are hyperthermic (fever) have poorer outcomes, controlling for other infections | Does aggressive treatment of hyperthermia improve outcomes | Is there a correlation with temperature and ICP, MAP, CPP and other parameters | CRF - data point locations; Ancillary data need (images, biomarkers) | David W. Wright | Lisa Merck | Geoff Manley | Tamara Espinoza | ||||||||||||||||||||||||||||
42 | 5/23/2014 13:51:00 | 5/1/2012 | Pratik Doshi | pratik.b.doshi@uth.tmc.edu | UT Houston Houston Texas | 713-500-7585 | Manuscript | Do patients admitted to Neurospecific ICUs do better than Trauma ICU | Do patients managed by a neurointensivist vs. Trauma alone do better | CRF - data point locations; Ancillary data need (images, biomarkers) | This is a simpler idea, with comparison of outcomes of patients with TBI treated in Neuro specific ICU versus a General trauma ICU. I do not believe that this has been shown at a large scale as it would be possible with the Protect Data | Pratik Doshi | David W. Wright | Lisa H. Merck | |||||||||||||||||||||||||||||||
43 | 5/23/2014 13:55:00 | 5/1/2014 | David W. Wright | David.wright@emory.edu | 49 Jesse Hill Jr. Drive Atlanta, GA 30303 | 404-779-1709 | Manuscript | Do laboratory values predict TBI severity and outcome? | Does WBC correlate with GCS and TBI severity when controlling for ISS | Do other lab values correlate with TBI severity when controlling for ISS, or predict ISS. | Do lab values predict outcome. | Correlation between lab initial lab values and TBI severity, ISS severity, GOSE or other outcome measures. Also look at Lab value trajectory over the first 7 days as a predictor of outcome. | David W. Wright | Lisa H. Merck | |||||||||||||||||||||||||||||||
44 | 5/23/2014 13:59:00 | 5/1/2012 | Victoria Mah | Does Experience Matter? Examining the Relationships between Disease Experience and Perceptions of Research in Emergency Settings | No | Does prior experience and medical knowledge of the TBI impact the EFIC decision and attitudes | CRF - data point locations; Ancillary data need (images, biomarkers) | The objective of the paper is to explore the relationship between personal experience with a disease/medical condition and attitudes towards emergency research using the exception from informed consent (EFIC), as well as knowledge about EFIC studies. Findings of differences in attitudes between those with personal disease experience and those without may guide institutional review boards and investigators in setting standards or guidelines for the community consultation component of emergency research | Victoria Mah | Rebecca Pentz | Neil Dickert | David Wright | Michelle Biros | HSP committee members | Yes | ||||||||||||||||||||||||||||||
45 | 8/15/2014 11:13:00 | 1/1/2012 | Lisa H. Merck | lisa_merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | JAMA or NEJM | Standardization of Cinical Care Across Sites in the ProTECTIII Clinical Trial | Yes | Standardization of clinical care is related to outcome in the control and treatment groups | Transgression compliance, associations, and elationship to outcome will be assessed accross cites, control and treatment groups. Demopgraphic, historical, and injury confounders will additionally be controlled for. | ultimately the stepwise regression of the historical, physiologic, imaging, ISS and transgression confounders will be run within one model. | CRF - data point locations | CRF, SAE, COD, WD, Transgression Data, ISS, Imaging | Lisa H. Merck MD MPH | Sharon Yeatts | Yuko Palesch | Mike Frankel | Robert Silbergleit | Geoff Manley | Yes | David Wright | ||||||||||||||||||||||
46 | 9/8/2014 14:50:00 | Imaging Group | Primary: Findings on baseline CT predict functional and neurocognitive outcome at 6 months | ||||||||||||||||||||||||||||||||||||||||||
47 | 9/8/2014 14:50:00 | Imaging Group | Primary: Findings on baseline CT predict response to progesterone treatment | ||||||||||||||||||||||||||||||||||||||||||
48 | 9/8/2014 14:50:00 | Imaging Group | Secondary-Hypothesis Driven: Findings on baseline CT are predictive of elevated ICP in the first 24 hours | ||||||||||||||||||||||||||||||||||||||||||
49 | 9/8/2014 14:50:00 | Imaging Group | Secondary-Hypothesis Driven: A novel Measure of cerebral contusion detected on baseline CT can be define and validated with high inter-rater agreement | ||||||||||||||||||||||||||||||||||||||||||
50 | 9/8/2014 14:50:00 | Imaging Group | Secondary-Hypothesis Driven: Cerebral contusion detected on baseline CT correlates with a) outcome and b) response to progesterone treatment | ||||||||||||||||||||||||||||||||||||||||||
51 | 9/8/2014 14:50:00 | Imaging Group | Secondary-Hypothesis Driven: A factorial analysis of baseline CT abnormalities (e.g. type, siz, location, multiplicity, etc) will identifyspecific finding that are predictive of a)outcome and b) response to progesterpone treatment | ||||||||||||||||||||||||||||||||||||||||||
52 | 9/8/2014 14:50:00 | Imaging Group | Secondary-Hypothesis Driven: A factorial analysis of baseline CT abnormalities will identify specific findings that correlate with baseline, 24 hour and 48 hour biomarker levels | ||||||||||||||||||||||||||||||||||||||||||
53 | 9/8/2014 14:50:00 | Imaging Group | Secondary-Hypothesis Driven: A new CT classification scheme can be created that is a better predictor of outcome than existing schemes (e.g. Marshall, Rotterdam and Abbrev Injury Scale) | ||||||||||||||||||||||||||||||||||||||||||
54 | 9/8/2014 14:56:00 | Imaging Group | Secondary-Descriptive Analyses: Describe the correlates of reversible imaging abnormalities detected on baseline CT | ||||||||||||||||||||||||||||||||||||||||||
55 | 9/8/2014 14:56:00 | Imaging Group | Secondary-Descriptive Analyses: Describve the correlation (and lack of correlation) between key findings on baseline CT and initial GCS | ||||||||||||||||||||||||||||||||||||||||||
56 | 9/8/2014 14:56:00 | Imaging Group | Secondary-Descriptive Analyses: Describe the evolution of baseline CT findings on subsequent imaging (e.g. natural history of contusion) and relationship to outcome prediction -> Bidrectional change (resolution vs increased lesion load) and ->Rate of chage | ||||||||||||||||||||||||||||||||||||||||||
57 | 9/8/2014 15:01:00 | Imaging Group | Tertiary- Assessment of inter-rate agreement/reliability through use of current central reading process by addtional reader/assessor | ||||||||||||||||||||||||||||||||||||||||||
58 | 9/8/2014 15:01:00 | Imaging Group | Tertiary-MRI within short timefram of CT (perferably baseline) to assess acurracy of CT lesion measurement: ->could have potential for slection bias; ->analysis could be kept to a particular pattern looking at pathalogical evolution and its relationship to outcome | ||||||||||||||||||||||||||||||||||||||||||
59 | 9/8/2014 15:01:00 | Imaging Group | Tertiary-Variability in methodology/practice pattern of different sites (frequency/types of imagin/view/dosage/resolution done) if information is available | ||||||||||||||||||||||||||||||||||||||||||
60 | 9/12/2014 18:48:00 | ||||||||||||||||||||||||||||||||||||||||||||
61 | 9/15/2014 8:53:00 | 9/1/2010 | Lisa H. Merck MD MPH | Lisa_Merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | Secondary analyses of historical and demographic confounders in the ProTECTIII study. | Yes | 1. Correlation analyses between potential demographic / historical confounders and outcome in control group (build regression model). Look at potential difference in outcome when controlling for the significant demographic and historical confounders between control and study group (outcome: NPT/GOSE/mortality). (ex confounders: age, gender, education level, hx depression, hx etoh, hx SA, hx TBI, hx multiple NPT, PHQ, employment hx, hx of disability prior to injury, comorbidity, concurrent pain or sedating medications, seizures, native language). | CRF - data point locations | Lisa H. Merck MD MPH | Sharon Yeatts | Yuko Palesch | Mike Frankel | Robert Silbergleit | Geoff Manley | Yes | David Wright | Yes | Lisa H. Merck MD MPH | lisa_merck@brown.edu | same | same | |||||||||||||||||||||
62 | 9/15/2014 8:54:00 | 9/1/2010 | Lisa H. Merck MD MPH | Lisa_Merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | Secondary analyses of physiologic variability and confounders of polytrauma with respect to outcome in the ProTECTIII study. | Yes | 2. A. Correlation analyses between total hours of individual physiologic transgressions and outcome, build regression model, look at potential difference between outcome (NPT/GOSE/mortality) in control and study group. B. Do the same for acceptable versus not acceptable transgressions (and assess demographics of compliance). | CRF - data point locations | Lisa H. Merck MD MPH | Sharon Yeatts | Yuko Palesch | Mike Frankel | Robert Silbergleit | Geoff Manley | Yes | David Wright | Yes | Lisa H. Merck MD MPH | lisa_merck@brown.edu | same | same | |||||||||||||||||||||
63 | 9/15/2014 9:01:00 | 9/1/2010 | Lisa H. Merck MD MPH | Lisa_Merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | Applying the ISS to patients with significant traumatic brain injury | Yes | 5. A. Break down the ISS by the organ systems, look at correlation between severity of injury per system, and outcome. Build logistic model based on significant contributors to mortality and morbidity. Assess relationship between treatment and outcome when controlling for confounders based on this advanced ISS analysis. Those that are not significant polytrauma confounders will be grouped with primary head injury for this analysis. B. compare predictive value of old ISS model, advanced ISS model, and Transgression models. | CRF - data point locations; Ancillary data need (images, biomarkers) | Lisa H. Merck MD MPH | Sharon Yeatts | Yuko Palesch | Robert Silbergleit | Geoff Manley | David Wright | Yes | Yes | ||||||||||||||||||||||||||
64 | 9/15/2014 9:02:00 | 9/1/2010 | Lisa H. Merck MD MPH | Lisa_Merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | Validation of the ISS in Patients with Traumatic Brain Injury and Polytrauma | Yes | 6. Assess advanced ISS, Transgression model, Marshall score, GCS with relationship to outcome / NPT. Compare to basic ISS. | CRF - data point locations; Ancillary data need (images, biomarkers) | Lisa H. Merck MD MPH | Sharon Yeatts | Yuko Palesch | Robert Silbergleit | Geoff Manley | David Wright | Yes | Yes | ||||||||||||||||||||||||||
65 | 9/15/2014 9:10:00 | 9/1/2010 | Lisa H. Merck MD MPH | Lisa_Merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | Correlation between imaging and outcome in the ProTECTIII Study | Yes | Differences in major categories of TBI on imaging will be correlated with different outcomes and response to treatment. (diffuse/focal/size/surgical versus contusion). A factorial analysis of baseline CT abnormalities (e.g. type, size, location, multiplicity, etc) will identify specific findings that are predictive of a) outcome and b) response to progesterone treatment (when controlling for major confounders outlined in historical and transgression data.) Relationship between findings on baseline CT and functional / neurocognitive outcome at 6 Months (control and treatment groups). | CRF - data point locations; Ancillary data need (images, biomarkers) | Lisa H. Merck MD MPH | Mike Lunney | Yuko Palesch | Robert Silbergleit | Geoff Manley | David Wright | Yes | Sharon Yeatts | Yes | |||||||||||||||||||||||||
66 | 9/15/2014 9:15:00 | 9/1/2010 | Lisa H. Merck MD MPH | Lisa_Merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | Methods paper | Yes | Description of Methods for ProTECTIII, CST Guidelines | CRF - data point locations; Ancillary data need (images, biomarkers) | Robert Silbergleit | Sharon Yeatts | Yuko Palesch | Vicki Hertzberg | Geoff Manley | Bill Barsen | Yes | Lisa H. Merck | David Wright | Yes | ||||||||||||||||||||||||
67 | 9/15/2014 9:16:00 | 9/1/2010 | Lisa H. Merck MD MPH | Lisa_Merck@brown.edu | 125 Whipple St, Providence, RI | 919.949.5536 | Manuscript | Clinical Standardization and Outcome | Yes | Mortality rates of patients in the ProTECTIII Cohort when compared to historical controls from the TRACS database | CRF - data point locations; Ancillary data need (images, biomarkers) | Lisa H. Merck MD MPH | Sharon Yeatts | Yuko Palesch | Mike Frankel | Robert Silbergleit | Geoff Manley | Yes | David Wright | Yes | |||||||||||||||||||||||||
68 | 9/17/2014 12:21:00 | 9/1/2010 | Manuscript | BioProTECT | Yes | Mike Frankel | Sharon Yeatts | Yuko Palesch | Robert Silbergleit | Robert Silbergleit | Geoff Manley | Yes | David Wright | Lisa H. Merck MD MPH | |||||||||||||||||||||||||||||||
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