ProTECT III publications submissions
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TimestampToday's dateOriginating author(s)E-mailAddressTelephoneProposed format(s)Target meeting or journalSubmission deadline or target completion dateMeeting date (if applicable)Meeting location (if applicable)Proposed TitleSDMC Data Analysis RequiredHypothesis / research question / objective 1Hypothesis / research question / objective 2Hypothesis / research question / objective 3Data needed for analysisBrief explanation of data requiredData requested byHypothesis Writing Group (additional investigators / authors)Comments
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5/14/2015 9:10:14Lunney, Ratcliffmlunney@emory.edu
49 Jesse Hill Jr. Dr. SE
Suite 126
Atlanta, GA 30303
404-778-1702Manuscriptunknown12/1/2015Characteristics of moderate and severe traumatic brain injury patients without abnormal findings on baseline computed tomography brain imaging.NoDescribe 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.ImagingDemographics, initial presentation, radiology form, additional images.5/20/2015D. Wright, V. Hertzberg, Matt Gregory (Emory biostats intern)In progress
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8/20/2015 5:21:06Jeremy 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
3/1/2016Hawaii
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
8/20/2015Tom Aufderheide,Melissa Mena
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7/14/2016 11:49:08Martin Schreiber, MDschreibm@ohsu.edu
Oregon Health & Science University
3181 S.W. Sam Jackson Park Road
Mail Code: L611
Portland, OR 97239
503 494-7883
ManuscriptJournal 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
9/12/2016A. Bommiasamy, C. Hilliard
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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
10/1/20163/5/2017Snowbird, 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
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4/22/2015 22:02:004/22/2015Neal Dickertnjr@emory.edu
1462 Clifton Road #508 Atlanta, GA 30322
404-712-6834ManuscriptResuscitation or Academic Emergency MedicineUnderstanding Relationships Between Clinical Outcome and Views of Inclusion in EFIC ResearchNoClinical 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 locationsWe need the primary clinical outcome and initial injury severity for patients included in PEER-ProTECT, for whom we have study ID numbers.5/30/2015Rebecca PentzDavid WrightLouisa Wallother authors of PEER-ProTECT manuscript will be invitedNoIn progressYes
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4/21/2015 13:42:004/21/2015Elizabeth Joneselizabeth.b.jones@uth.tmc.edu
6431 Fannin, JJL446 Houston, TX 77030
713-446-4786Post-traumatic seizures in patients in the ProTECT-III study.YesIs there a difference in post-traumatic seizure rates among ProTECT-III patients treated with different prophylactic agents, or no prophylactic agent?CRF - data point locationsdemographics, GCS data, seizure prophylaxis given, adverse events.On hold, did not have data for initial idea, but relook. In Jones courtYes
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3/4/2015 11:35:003/4/2015Jonathan Ratcliffjratcli@emory.edu
49 Jesse Hill Jr Drive Atlanta, GA 30303
ManuscriptOptimization 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 locationsReview of outcome measures would be required.Clarification neededYes
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3/4/2015 11:27:003/4/2015Jonathan Ratcliffjratcli@emory.edu
49 Jesse Hill Jr Drive Atlanta, GA 30303
ManuscriptCommon sedation agents in the care of TBI patients and the relationship with outcomeThere is no drug used more liberally in the care of the severe TBI patient than sedation yet little is known about the influence on outcomeDescribe epidemiology of sedation use and relationship to vent days, ICU LOS, in hospital mortalitySecondary relationships with BP, CPP and ICP could be analyzed.CRF - data point locationsDont have the dataYes
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3/4/2015 11:21:003/4/2015Jonathan Ratcliffjratcli@emory.edu
49 Jesse Hill Jr Drive Atlanta, GA 30303
ManuscriptWhen are platelets being transfused and what is the relationship with outcome?Describe the current practice of platelet transfusion - who gets plateletsWhat 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
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3/4/2015 11:15:003/4/2015Jonathan Ratcliffjratcli@emory.edu
49 Jesse Hill Jr Drive Atlanta, GA 30303
ManuscriptThe role of progesterone in mitigating hemorrhage expansion on serial head CTsProgesterone 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 projectYes
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3/4/2015 11:11:003/4/2015Jonathan Ratcliffjratcli@emory.edu
49 Jesse Hill Jr Drive Atlanta, GA 30303
4047781714ManuscriptRisk factors for developing coagulopathy after TBI and the role of progesterone to mitigate these effectsCoagulopathy after TBI is common yet little is known about risk factors - who becomes coagulopathicAlso, 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 projectYes
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3/4/2015 11:02:003/4/2015Jonathan Ratcliffjratcli@emory.edu
49 Jesse Hill Jr Drive Atlanta, GA 30303
404778-1714ManuscriptThe 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 locationsMonocyte count at admission and outcome would be required. In addition, general predictors of outcome following TBI would be necessary.Opeolu Adeoye - CincinnatiLab considered dataYes
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2/3/2015 16:12:002/3/2015Pratik DoshiPratik.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
8323148062Oral Presentation; ManuscriptCritical Care MedicineEffect of Oxygenation and ventilation in the immediate injury period on outcomes in patients suffering from Traumatic brain injuryYesThere 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 DoshiElizabeth Jonesother interested parties welcomeYes
Likely in Transgression paper. Will reeval post this paper,
Group with Transgression paperYes
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1/15/2015 13:59:001/15/2015Liqiong Fanfanliq@musc.edu
315 Queens CT APT B, Mt. Pleasant, S.C, 29464
8437438734Abstract; Oral Presentation; ManuscriptSCT, ISC, Statistics in Medicine, StrokeThe impact of covariate misclassification using generalized linear regression under covariate-adaptive randomization.Noimpact of misclassification on the estimation for the treatment effectCRF - data point locations; Ancillary data need (images, biomarkers)Sharon D. YeattsYuko Y. PaleschUnder revision, does not need PUB reviewYes
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12/16/2014 14:08:0012/16/2014Jeremy Brownjeremy.brown@nih.gov
45 Center Drive Bethesda MD 20892
301-594-4481ManuscriptTBAWithdrawing permission for study participation after enrollment via EFICAnalysis of the LAR/subject who withdrew permission to be in the PROTECT III trial once after the patient ha already been enrolled via EFICOther data sourcechart or enrollment notes as to more specific reason why LAR or patient withdrew permission after randomization and treatment had begun.Wright DNoJosh Salsman abstract similar. Let Josh know JB interested - writing up the paper. Yes
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11/20/2014 17:05:0011/20/2014David Wrightdavid.wright@emory.edu4047781709ManuscriptIs ventriculostomy superior to Subarachnoid bolt for ICP monitoring in TBIYesOutcomes of Bolt vs. VentricAdverse events of Bolt vs. VentricCRF - data point locations; Ancillary data need (images, biomarkers)Bolt vs. Ventric. Decompressive Crani, mortality, GOSE Adverse events - Neuro infections/new bleeds, other relevant SAEsLisa MerckGeoff Manleyother members of CST teamYes
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11/9/2014 17:40:0011/9/2014Eric Sribnickeric.sribnick@gmail.com
5455 Meridian Mark Road NE Atlanta, GA 30342-1654
8437226736ManuscriptJournal of Neurotrauman/aRetrospective analysis of a population of traumatic brain injury patients using the Surgical Intervention for Traumatic InjuryNoWe 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 sourceThe 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.12/1/2014Poster, publication, need to reach out?Yes
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10/14/2014 12:40:0010/14/2014Robert D. Welchrwelch@med.wayne.edu
Department of Emergency Medicine Detroit Receiving Hospital, 6G/UHC 4201 St. Antoine, Detroit, MI 48201
313-993-2534Abstract; ManuscriptNot yet sure of target for abstract Journal Neurotrauma or Academic EMEarly Deaths and Unexpected Good Outcomes in TBI Patients - Rationale for Selecting Patients in Future TBI StudiesYesThere 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.1/31/2015YesIn Progress, Rob looking at DataYes
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10/3/2014 17:14:0010/3/2014Nina Gentile, MDngentile@temple.edu
Broad and Ontario Streets Temple University School of Medicine Philadelphia, PA
215-707-8402Abstract; ManuscriptFavorable 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 sourceResponses to community consultation questionsTamera MeansSumaya MekkaouiHannah Reimer, RNSend to HSP working group and PUB group to review and comment. Their shop data.Yes
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9/29/2014 19:41:009/29/2014Dr. John Wanebo and Lori Wood RNLwood@shc.org
Scottsdale Healthcare Osborn Medical Center 7400 E. Osborn Road, Scottsdale AZ 85251
480-882-5646ManuscriptJournal of TraumaYesThere 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 WaneboDr. Joseph ZabramskiLori Wood RNVeronica Place RNDr. Kurt DenninghoffBruce Barnhart RNYesSend Database, they can reviewYes
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9/28/2014 21:02:009/28/2014Chris Lewandowskiclewand1@hfhs.org
2799 W Grand Blvd, Detroit, MI 48202
313-876-1552ManuscriptTBDOutcomes Among TBI Patients with Normal Initial Neuroimaging.YesProgesterone 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 levelsCRF - data point locations; Ancillary data need (images, biomarkers)subjects with normal CT findings n=125 mpl 11.12.14Joseph Miller
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9/28/2014 20:55:009/28/2014Joseph Millerjmiller6@hfhs.org
2799 W Grand Blvd, Detroit, MI 48202
313-492-7381ManuscriptInteraction of Vitamin D Deficiency and Progesterone in the ProTECT III TrialYesVitamin D deficiency impacts the effect of progesterone on 6-month outcomesFor 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 specimensChris Lewandowski
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9/28/2014 20:34:009/28/2014Joseph Millerjmiller6@hfhs.org
2799 W Grand Blvd, Detroit, MI 48202
313-492-7381ManuscriptTBDGender difference in TBI injury patternsYesFemale TBI patients demonstrate different patterns of brain injury than male counterpartsFemale TBI patients demonstrate different systemic injury patterns (non-CNS) than their counterpartsCRF - data point locations; Ancillary data need (images, biomarkers)Baseline CRF data, CT imaging classification, ISS detailsChris Lewandowski
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9/25/2014 17:27:009/25/2014M Lunneymlunney@emory.edu
49 Jesse Hill Jr. Dr. SE Suite 126 Atlanta, GA 30303
404-778-1702Abstract; ManuscriptEffects of progesterone on outcomes in traumatic subarachnoid hemorrhage.Yes1º 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 locationsForm 0, form 3, form 9, form 12, form 16, form 36, form 37.David WrightLisa MerckJason AllenYes
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9/24/2014 17:19:009/24/2014Josh Salzmanjoshua.g.salzman@healthpartners.com
640 Jackson St. MS: 11109F
651-254-5302Abstract; Oral Presentation; ManuscriptNational Association of EMS Physicians; Prehospital Emergency Care; Potential trauma meetings (AAST, EAST - due March 2015)8/14/20151/14/2016San Diego, CAAssociation between prehospital intubation and TBI outcome (control group only)NoWith 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 locationsCRFs 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"12/1/2014Michelle BirosSandi WewerkaBruce BennettDavid DriesYesYes
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9/24/2014 17:10:009/24/2014Josh Salzmanjoshua.g.salzman@healthpartners.com
640 Jackson St. MS: 11109F
651-254-5302Abstract; Oral Presentation; ManuscriptSociety for Academic Emergency Medicine12/12/20145/12/2015San Diego, CAFrequency of sedation-induced hypotension between time of injury to time of ICU admissionYesHow frequently did this patients experience hypotension related to medication administration in the first 24 hours from time of injury?CRF - data point locationsPatient demographics, hypovolemia transgression sheet.11/3/2014Michelle BirosSandi WewerkaBruce BennettDavid DriesYesYes
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9/24/2014 17:02:009/24/2014Josh Salzmanjoshua.g.salzman@healthpartners.com
640 Jackson St. MS: 11109F
651-254-5302Abstract; Oral Presentation; ManuscriptSociety for Academic Emergency Medicine / Academic Emergency Medicine12/12/20145/12/2015San Diego, CAAssociation between Consent Decision (consent vs. decline) and Patient PrognosisNoHypothesis: Consent for continued participation was denied more frequently for patients with good prognosis at the time of the consent decisionHypothesis: Consent for continued participation was denied more frequently for patients with good neurologic outcomeCRF - data point locationsAll data fields from Informed Consent log, including date and time of consent or declined consent decision; patient demographic information, GOSE at 6 months11/3/2014Michelle BirosYes
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9/24/2014 16:57:009/24/2014Josh Salzmanjoshua.g.salzman@healthpartners.com
640 Jackson St. MS:11109F St. Paul, MN 55101
651-254-5302Abstract; Oral Presentation; ManuscriptSociety for Academic Emergency Medicine / Academic Emergency Medicine12/12/20145/12/2015San Diego, CAProcess Metrics for Informed Consent following enrollment under EFICYesDescribe 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 decisionCRF - data point locationsAll data fields from the Informed consent log; patient demographics; time of injury; time to medication start11/3/2014Michelle BirosYes
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9/24/2014 12:47:009/24/2014Valerie Stevensonvwillis@umich.eduNETT CCC7342322141Abstract; Lecture; ManuscriptTBDCost considerations in EFIC trials/CC and PD processesNoHow do we budget CC/PDWhat do we need for CC/PDOther data sourceSurvey/interview data from sites involved in the CC/PD processTBD based on interestYesYes
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9/22/2014 13:36:009/22/2014Hannah Reimerhreimer@temple.edu
Temple University Department of Emergency Medicine 3401 N. Broad St. Phila., PA 19140
2157075483Abstract; ManuscriptUse of One Social Network Site in Community Consultation and Public Disclosure for an Exception From Informed Consent TrialNoMethods paper describing how social media was used in EFIC activitiesNina GentileBrent FreemanPatricia McNelisVernon KalugdanNoYes
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9/17/2014 11:57:009/17/2014Mike Lunneymlunney@emory.edu
49 Jesse Hill Jr. Dr. SE Suite 126 Atlanta, GA 30303
404-778-1702ManuscriptEffects on outcome and mortality of progesterone based on CT imaging components of Rotterdam score.Yes1º 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 locationsForm 3, form 9, form 12, form 16.D WrightJ AllenL MerckNo
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9/17/2014 11:32:009/17/2014Christy Stehlychristy.stehly@sluhn.org
St. Luke's University Health Network 801 Ostrum Street Bethlehem, PA 18015
484-526-6076Abstract; Oral Presentation; ManuscriptTBDUtilizing an on-call research assistant model to optimize enrollments in emergent treatment trialsYesCRF - data point locations; Other data sourceYes
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9/16/2014 16:23:009/16/2014Valerie Mikavmika@med.wayne.edu
4201 St. Antoine UHC- 6G
3137454350Abstract; Oral Presentation; ManuscriptOutcome 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 GCSDoes 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 dataYes
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5/6/2014 9:57:005/6/2014David W. Wrightdavid.wright@emory.edu
49 Jesse Hill Jr. Drive, Atlanta GA 30303
404-778-1709ManuscriptManuscript - NEJM8/1/2014ProTECT III: Phase III Efficacy Trial of Progesterone for the treatment of Acute Traumatic Brain InjuryYesDoes 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 locationsNeed CRF data and imaging5/7/2014Robert SilbergleitSharon YeattsYuko PaleschVicki HertzbergGeoff ManleyBill BarsenYesLisa H. MerckDavid W. Wrightdavid.wright@emory.edusamesame
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5/22/2014 16:57:004/29/2014Samir Belagajesbelaga@emory.edu
FOB 374 80 Jesse Hill Jr. Drive SE Atlanta, GA 30303
404-879-0348ManuscriptNeurology or J Neuro RepairThe Impact of Rehabilitation / Post Hospital Discharge Disposition on Outcomes in the ProTECT III StudyYesSubjects who went home or to acute Rehab had better outcomes than those who were discharged to a SNFWas there an imbalance in the discharge disposition between 2 arms (ProgvsPlac) which could have served as a confounderIf, imbalance - did it affect overall resultsCRF - data point locationsGCS initial, GCS hospital d/c, Discharge disposition, demographicsSamir BelagagiYes
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5/22/2014 17:03:005/1/2014David WrightDavid.wright@emory.edu
49 Jesse Hill Jr. Drive Atlanta GA 30303
404-778-1709ManuscriptTBDValidation of the IMPACT Prediction Model using the ProTECT III TrialYesThe IMPACT Prediction Model will accurately predict overall mortality and morbidity of subjects in the ProTECT III trialOther Prediction modelsCRF - data point locationsUse the IMPACT online Prediction Model and compare to the actual ProTECT III outcomesDavid W. WrightTamara EspinozaGeoff ManleyLisa H. MerckYes
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5/22/2014 17:12:005/1/2013Kurt Denninghoffkdenninghoff@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) 626-1551ManuscriptTBDPatterns and Comparisons of EFIC vs. Non-EFIC subjects in the ProTECT III trialYesAre there specific differences between the EFIC enrolled subjects vs. the Non-EFIC enrolled subject.CRF - data point locations; Other data sourceKurt DenninghoffDavid WrightDeneil and members of HSP writing groupYes
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5/22/2014 17:31:005/2/2011Michelle Birosbiros001@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
ManuscriptUnanticipated circumstances related to implementation of an EFIC TrialNoExplore the unanticipated circumstances around implementation of EFIC - descriptiveCRF - data point locations; Other data sourceShowcase examples of several fascinating EFIC enrollment cases during the ProTECT III trial and provide Ethical commentary for each case.Michelle BirosDavid WrightDeneil HarneyNeil DickertVictoria MahKatie LammondYesKurt DenninghoffRebecca PentzJill BarenErin BengelinkLisa MerckYes
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5/23/2014 13:44:005/1/2012Pratik Doshipratik.b.doshi@uth.tmc.edu
UT Health Science Center at Houston Houston, TX
713-500-7585ManuscriptThe Impact of Hypothermia on patient outcomes in the ProTECT III trialYesDo patients who present hypothermic have better outcomes than normothermicEvaluation of temperature curve profile and outcomeCRF - data point locationsBased 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 DoshiDavid W. WrightYes
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5/23/2014 13:48:005/1/2012David W. Wrightdavid.wright@emory.edu
49 Jesse Hill Jr. Drive Atlanta GA 30303
404-778-1709ManuscriptThe Effect of temperature and temperature control on patient outcome in the ProTECT III trialYesDo patients who are hyperthermic (fever) have poorer outcomes, controlling for other infectionsDoes aggressive treatment of hyperthermia improve outcomesIs there a correlation with temperature and ICP, MAP, CPP and other parametersCRF - data point locations; Ancillary data need (images, biomarkers)David W. WrightLisa MerckGeoff ManleyTamara Espinoza
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5/23/2014 13:51:005/1/2012Pratik Doshipratik.b.doshi@uth.tmc.edu
UT Houston Houston Texas
713-500-7585ManuscriptDo patients admitted to Neurospecific ICUs do better than Trauma ICUDo patients managed by a neurointensivist vs. Trauma alone do betterCRF - 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 DataPratik DoshiDavid W. WrightLisa H. Merck
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5/23/2014 13:55:005/1/2014David W. WrightDavid.wright@emory.edu
49 Jesse Hill Jr. Drive Atlanta, GA 30303
404-779-1709ManuscriptDo laboratory values predict TBI severity and outcome?Does WBC correlate with GCS and TBI severity when controlling for ISSDo 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. WrightLisa H. Merck
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5/23/2014 13:59:005/1/2012Victoria MahDoes Experience Matter? Examining the Relationships between Disease Experience and Perceptions of Research in Emergency SettingsNoDoes prior experience and medical knowledge of the TBI impact the EFIC decision and attitudesCRF - 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 researchVictoria MahRebecca PentzNeil DickertDavid WrightMichelle BirosHSP committee membersYes
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8/15/2014 11:13:001/1/2012Lisa H. Mercklisa_merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptJAMA or NEJMStandardization of Cinical Care Across Sites in the ProTECTIII Clinical TrialYesStandardization of clinical care is related to outcome in the control and treatment groupsTransgression 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 locationsCRF, SAE, COD, WD, Transgression Data, ISS, ImagingLisa H. Merck MD MPHSharon YeattsYuko PaleschMike FrankelRobert SilbergleitGeoff ManleyYesDavid Wright
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9/8/2014 14:50:00Imaging GroupPrimary: Findings on baseline CT predict functional and neurocognitive outcome at 6 months
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9/8/2014 14:50:00Imaging GroupPrimary: Findings on baseline CT predict response to progesterone treatment
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9/8/2014 14:50:00Imaging GroupSecondary-Hypothesis Driven: Findings on baseline CT are predictive of elevated ICP in the first 24 hours
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9/8/2014 14:50:00Imaging GroupSecondary-Hypothesis Driven: A novel Measure of cerebral contusion detected on baseline CT can be define and validated with high inter-rater agreement
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9/8/2014 14:50:00Imaging GroupSecondary-Hypothesis Driven: Cerebral contusion detected on baseline CT correlates with a) outcome and b) response to progesterone treatment
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9/8/2014 14:50:00Imaging GroupSecondary-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
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9/8/2014 14:50:00Imaging GroupSecondary-Hypothesis Driven: A factorial analysis of baseline CT abnormalities will identify specific findings that correlate with baseline, 24 hour and 48 hour biomarker levels
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9/8/2014 14:50:00Imaging GroupSecondary-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)
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9/8/2014 14:56:00Imaging GroupSecondary-Descriptive Analyses: Describe the correlates of reversible imaging abnormalities detected on baseline CT
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9/8/2014 14:56:00Imaging GroupSecondary-Descriptive Analyses: Describve the correlation (and lack of correlation) between key findings on baseline CT and initial GCS
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9/8/2014 14:56:00Imaging GroupSecondary-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
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9/8/2014 15:01:00Imaging GroupTertiary- Assessment of inter-rate agreement/reliability through use of current central reading process by addtional reader/assessor
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9/8/2014 15:01:00Imaging GroupTertiary-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
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9/8/2014 15:01:00Imaging GroupTertiary-Variability in methodology/practice pattern of different sites (frequency/types of imagin/view/dosage/resolution done) if information is available
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9/12/2014 18:48:00
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9/15/2014 8:53:009/1/2010Lisa H. Merck MD MPHLisa_Merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptSecondary analyses of historical and demographic confounders in the ProTECTIII study.Yes1. 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 locationsLisa H. Merck MD MPHSharon YeattsYuko PaleschMike FrankelRobert SilbergleitGeoff ManleyYesDavid WrightYesLisa H. Merck MD MPHlisa_merck@brown.edusamesame
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9/15/2014 8:54:009/1/2010Lisa H. Merck MD MPHLisa_Merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptSecondary analyses of physiologic variability and confounders of polytrauma with respect to outcome in the ProTECTIII study.Yes2. 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 locationsLisa H. Merck MD MPHSharon YeattsYuko PaleschMike FrankelRobert SilbergleitGeoff ManleyYesDavid WrightYesLisa H. Merck MD MPHlisa_merck@brown.edusamesame
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9/15/2014 9:01:009/1/2010Lisa H. Merck MD MPHLisa_Merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptApplying the ISS to patients with significant traumatic brain injuryYes5. 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 MPHSharon YeattsYuko PaleschRobert SilbergleitGeoff ManleyDavid WrightYesYes
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9/15/2014 9:02:009/1/2010Lisa H. Merck MD MPHLisa_Merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptValidation of the ISS in Patients with Traumatic Brain Injury and PolytraumaYes6. 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 MPHSharon YeattsYuko PaleschRobert SilbergleitGeoff ManleyDavid WrightYesYes
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9/15/2014 9:10:009/1/2010Lisa H. Merck MD MPHLisa_Merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptCorrelation between imaging and outcome in the ProTECTIII StudyYesDifferences 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 MPHMike LunneyYuko PaleschRobert SilbergleitGeoff ManleyDavid WrightYesSharon YeattsYes
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9/15/2014 9:15:009/1/2010Lisa H. Merck MD MPHLisa_Merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptMethods paperYesDescription of Methods for ProTECTIII, CST GuidelinesCRF - data point locations; Ancillary data need (images, biomarkers)Robert SilbergleitSharon YeattsYuko PaleschVicki HertzbergGeoff ManleyBill BarsenYesLisa H. MerckDavid WrightYes
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9/15/2014 9:16:009/1/2010Lisa H. Merck MD MPHLisa_Merck@brown.edu
125 Whipple St, Providence, RI
919.949.5536ManuscriptClinical Standardization and OutcomeYesMortality rates of patients in the ProTECTIII Cohort when compared to historical controls from the TRACS databaseCRF - data point locations; Ancillary data need (images, biomarkers)Lisa H. Merck MD MPHSharon YeattsYuko PaleschMike FrankelRobert SilbergleitGeoff ManleyYesDavid WrightYes
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9/17/2014 12:21:009/1/2010ManuscriptBioProTECTYesMike FrankelSharon YeattsYuko PaleschRobert SilbergleitRobert SilbergleitGeoff ManleyYesDavid WrightLisa H. Merck MD MPH
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