All-Site Call

February 6, 2026

Agenda

Study Timeline

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Study Timeline

• Award entered an NCE in January pending completion of Y1 milestones

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• February 2026: 1^st site released to enroll
• February 2026: 1^st participant randomized
• End of April 2026: 50% sites CIRB approved
• End of May 2026: 50% sites released to enroll

Sites with Local IRB Ceding Acknowledgement Accepted in WebDCU: 30 / 69

• Banner University Medical Center
• Children’s Hospital Los Angeles
• Children's Hospital of Wisconsin
• Children's Medical Center UTSW
• Children's National Medical Center
• Froedtert Hospital
• Harbor-UCLA Medical Center
• Harborview Medical Center
• IU Health Methodist Hospital
• Johns Hopkins Hospital
• Memorial Hermann Texas Medical Center
• Nationwide Children's Hospital
• Northwestern Memorial Hospital
• Oregon Health & Sciences University Hospital
• OSU Wexner Medical Center

• Reading Hospital
• Riley Hospital for Children/IU Health
• Ronald Reagan UCLA Medical Center
• Rush University Medical Center
• Stanford University Medical Center
• Temple University Hospital
• UC Davis Medical Center
• University of Maryland Medical Center
• University of Michigan University Hospital
• University of Minnesota Masonic Children's Hospital
• University of Minnesota Medical Center
• University of New Mexico Hospital
• UPMC Presbyterian Hospital
• UVA Medical Center
• VCU Medical Center
• Yale New Haven Hospital

Sites with initial EFIC activities completed: 17 / 69

• Arthur M. Blank Hospital
• Children’s National Medical Center
• Christiana Hospital
• Emory University
• Grady Memorial Hospital
• Harborview Medical Center
• Memorial Hermann Texas Medical Center
• Nemours Children’s Hospital of Delaware
• Oregon Health & Sciences University Hospital

• Temple University Hospital
• UC Davis Medical Center
• UCSF Medical Center
• University of Michigan University Hospital
• UVA Medical Center
• San Francisco General Hospital
• Stanford University Medical Center
• Yale New Haven Hospital

Sites with Readiness Calls completed: 4 / 69

Sites with CIRB approval: 2 / 69

• Harborview Medical Center
• Temple University Hospital
• UC Davis Medical Center
• Yale New Haven Hospital

• Temple University Hospital
• Yale New Haven Hospital

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Contracts & Payments

• Award entered a NCE in January
• Contract extensions in progress between Michigan & hubs: required before site payments can be processed

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• Milestone start-up payments ($10,000 ea. including F&A):
• #1: Local IRB ceding approval; eDOA accepted; Local Context Form; UAB intake meeting; plans for 2 in-person CC events
• #2: Readiness call completed & open to enrollment

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Site Readiness

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Readiness: What should we be doing?

Use the checklist! KESETT.org > Getting started > Blue button

Study Team

Site Addresses

Regulatory Documents

Regulatory Documents

Regulatory Documents

Regulatory Documents

EFIC

Central IRB (CIRB) Tables

Steps 1 & 2 in WebDCU v1 > SIREN:

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Central IRB (CIRB) Tables

Step 3 in WebDCU v2 > KESETT:

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IRB Approval Process

Site submits local ICF language to CCC

Site completes initial site submission form

Site information added to local ICFs

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CCC submits site application to CIRB

Preparing for CIRB Submission

Readiness Calls SOP

• Vince will contact site to schedule once EFIC report is finalized by UAB and CIRB submission is complete/in queue

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• Once scheduled, Vince will share the site-specific Readiness Checklist
• Site study team completes Checklist at least 24-48 hours in advance to confirm call
• Aim to have very few/no remaining action items after the call

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Release to enroll

• After readiness call, if CIRB approved & no major outstanding issues, site will be Released to Receive Study Supplies
• Triggers study drug shipment

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• Once study drug is checked in at site, final administrative review > Released to Enroll

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EFIC Activities

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EFIC Activities

CC Community Event Documentation

• CCC is reviewing and asking for clarifications

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• Key information to include
• Why this event was chosen
• duration of event and team presence
• Which team members attended
• Community attendance - At event and contacted
• Number engaged in ~10 min conversations (consulted)
• Examples of conversations, questions, or impact
• Demographics - At event and extended discussion
• Overall reception and feedback including any opt-outs

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CC Community Event Documentation

• CCC is reviewing and asking for clarifications

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• Key information to include
• Why this event was chosen
• duration of event and team presence
• Which team members attended
• Community attendance - At event and contacted
• Number engaged in ~10 min conversations (consulted)
• Examples of conversations, questions, or impact
• Demographics - At event and extended discussion
• Overall reception and feedback including any opt-outs

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Investigators X, and Y along with PSC Z attended the Gotham Farmers Market to introduce the KESETT study. The study members had a booth at the market for the full duration (09:00 to 14:00) and handed out EFIC-approved fliers and pamphlets. The market patrons were non-specific members of the general public, although attending study members noticed that most patrons who stopped to learn about the study either knew someone with epilepsy, were healthcare workers, or were interested in the neurosciences. The most common question revolved around what a patron without a history or predisposition of seizures could do to support the study. Study members encouraged the patrons to inform people they know of the study and encourage others to register their interest in the Focus Groups via the survey provided in the UAB-created website. Patrons tended to understand the concept of EFIC and did not have any questions regarding that topic. Overall, market patrons responded encouragingly to this study and did not have many questions or comments. No opt out mechanisms were requested.

Investigators X and Y along with PSC Z attended the Gotham Farmers Market to talk to people for it’s 5 hour duration. Gotham Farmers Market is one of the cities largest and well attended gatherings, drawing over 10,000 visitors every week from a wide area. The market is dedicated to diversity and food justice and attracts customers of all socioeconomic groups by emphasizing acceptance of EBT/SNAP, WIC and Senior FMNP. Many people stopped by the booth to pick up fliers and brochures about the study and the study team was able to have discussions with about 200 people. Discussions differed in duration. Most were brief, but many (10 or more) were 10 minutes or longer. The event allowed us to talk to young and old people of many colors and backgrounds. Many of the patrons who stopped to learn about the study either knew someone with epilepsy, some were interested in science, some with prior experience with research, and some were healthcare workers. People talked to expressed support for the research. One father of a child with epilepsy described their difficulty dealing with the disease and expressed gratitude for the study Many of those with whom we talked who didn’t have epilepsy or seizures, asked what they could do to help. They were told to help spread the word by telling friends and family about it. Some expressed interest in the focus groups as well. People tended to understand the concept of EFIC and did not ask questions about that much. Overall, those with whom we engaged responded encouragingly to this study and did have any concerns. No opt out mechanisms were requested.

CC Focus group Documentation

• Entered into WebDCU by the UAB EFIC team

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• Site responsibilities
• Recruit attendees
• Provide list of attendees and why they were invited to UAB
• Propose times to the UAB facilitator
• Present study information on the call (facilitator guide)
• Answer attendee questions
• Keep record of what organizations or groups were contacted

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Focus Group Invitation

Focus Group Best Practices

Focus Group Recruitment

• Who?
• Local epilepsy and seizure disorder community
• Interested or invested community members
• Do not need to have a direct link to epilepsy or seizures
• Diverse backgrounds
• Representative of your community
• Include concerns specific for your community
• Minorities and underrepresented
• Low income or unhoused
• Faith based

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Focus Group Recruitment

Focus Group Recruitment

Source Documents

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Source Docs & CRFs

• Source document for all data recorded in the CRFs is the 1st location where those data are recorded.
• eCRF itself (data is observed & directly data entered)

*Add note to General comments filed stating “direct data entry”

• Paper case report form representative of the study eCRF
• Electronic health record
• Paper medical record

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Source Doc Hierarchy:

Clinical Outcomes at 15- & 60-min

1. Contemporaneous observation & documentation of attending physician’s determination

Directly recorded on paper or electronic CRF

• Direct communication with the attending physician

Directly recorded on paper or electronic CRF

• Medical record - explicit study-specific documentation
• Medical record - implicit review (should be used in very rare cases)

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Source Docs & CRFs

• Use CRFs as guide if you are creating your own source documents for clinical and study teams
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Source Docs & CRFs

• Can export/print as pdf or use as guide to build your own form
• Remember GCP guidelines & ALCOA-C if using a paper source document!

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Study Materials

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Study “Kit” Materials: Centrally provided

• Ceribell (unless using own clinical device):
• Recorder device
• KESETT stickers for recorder
• Ceribell headbands
• KESETT stickers for headband boxes
• Ceribell headband basket for IV pole
• Protocol Reminder Cards
• Length-based-weight estimation

measuring tape

• Can also be used to measure head circumference

Ceribell Supply Logistics

> Device provided after site contract is executed to allow local approvals.

> Headbands sent to sites after CIRB approval

> Headbands come in 2 sizes:

• Small (C151)
• Medium/Large (C152)

> Each site will have a set par for number of headbands on site.

> Headbands expire after ~6 months;

will have expiration date on box.

Ceribell: Headband Inventory & Resupply

1. Sites will complete monthly inventory survey.
• Can be completed anytime; must be completed at least 1x/month
• Responses submitted by 1st of month will be used to place monthly resupply orders by central team on 3rd of month.
2. Central team uses survey responses to bring each site up to full par.
• Sites receive shipment tracking info once order is fulfilled.
• Will use shipping address in WebDCU
3. Urgent resupply can be triggered by the site or central team.
• Site can use survey to indicate urgent request.
• Central team will monitor use based on enrollment CRFs.

Ceribell Inventory Survey

• REDCap survey
• Link in MoP

Data Coordinating Center (DCC)

WebDCU Access

• KESETT is the first SIREN study hosted in WebDCUv2

https://webdcu.musc.edu/DCUApp/Login

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• Permissions are granted based on eDOA roles and responsibilities.

WebDCU

• KESETT is a live database. DO NOT enter test data.

Enrollment

• KESETT is a step forward randomization design, which means we do not have a Randomization Form in WebDCU that assigns a treatment when submitted.
• Instead, sites will grab the ‘Use Next’ vial (or ‘Backup’ vial if no ‘Use Next’ is available) and use it to treat the KESETT participant.

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Enrollment

• Data entry into WebDCU will occur after enrollment.
• This includes documentation of Study Drug ID, which will tell the DCC which treatment assignment the participant received.

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Within 8 hours of KESETT study drug administration…

• Login to WebDCUv2
• Click on the KESETT tile
• Select Subject Enrollment on the main menu bar
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• Select Add Record

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Within 8 hours of KESETT study drug administration…

• Enter Subject Enrollment form and select Save Record

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Within 8 hours of KESETT study drug administration…

• Select green arrow to go to Subject Binder

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Within 8 hours of KESETT study drug administration…

• Data enter and submit other enrollment CRFs (F501 and F502)

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DCC Resources

• SIREN Website
• Data Collection Guidelines
• WebDCUv2 User Manual

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• Contact us
• Riley Luckmann (luckmann@musc.edu)
• Morgan Davie (daviem@musc.edu)
• Sara Meyer (butlers@musc.edu)

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Hot Tips

Thank you!

kesett.org

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Next All-site call: Friday, March 6

Enrollment Video

Premises

• KESETT should never delay treatment of �status epilepticus
• KESETT is based upon guideline �Concordant treatment of status

Inclusion Criteria�

1. The patient was witnessed to have a convulsive seizure for greater than 5-minute duration.

2. The patient received an adequate dose of benzodiazepines. The doses may be divided.

3. The last dose of a benzodiazepine was administered 5-30 minutes before study drug administration.

4. Continued or recurring seizures in the Emergency Department.

5. Age 1 year or older.

6. Known or estimated weight ≥ 10 kg

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Exclusion Criteria�

1. Known pregnancy (lab testing not indicated for screening)

2. Prisoner.

3. Opt-out identification or otherwise known to be previously enrolled in KESETT.

4. Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital, or other agents defined in the MoP) for this episode of status epilepticus (SE).

5. Treatment with sedatives with anticonvulsant properties other than benzodiazepines for this episode of SE (propofol, etomidate, ketamine, or other agents defined in the MoP).

6. Endotracheal intubation prior to enrollment.

7. Acute traumatic brain injury clearly precedes seizures.

8. Scalp injury or burn preventing EEG placement.

9. Known allergy or other known contraindication to KET or LEV.

10. Hypoglycemia < 50 mg/dL

11. Hyperglycemia > 400 mg/dL

12. Cardiac arrest / post-anoxic seizures

Abbreviated Eligibility

Inclusion

1. Convulsive seizure > 5 minutes

2. Seizures continue/recur in ED

3. Seizure despite adequate dose of benzos

4. Seizure despite properly timed benzo

5. Age ≥ 1 year & est. wgt > 10kg

Exclusion

1. Hypoglycemia, TBI, cardiac arrest

2. Known contraindication to drugs or EEG

3. Already received 2nd line agent or anesthetic

4. Already intubated

5. EFIC prohibited - known pregnancy, prisoner or opt out identification�

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Reminder Cards with instructions

Length-based weight-estimation tool

Study Ceribell with headbands in a basket below

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Retrieved KESETT study drug spiked and inverted on hanger tab

Your institutional pump

Vials

Vials contain LEV and KET (or LEV alone)

Same concentration in all vials

Purple tier 35mL - Weight 30kg

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Drug ID on the vial

White tier 90mL - Weight 30kg

Use next vials and backup vials

Storage, replacement and shipping

Cavalry to the rescue

Study team needs to arrive as soon as possible

1. Start or confirm EEG

2. Retrieve vial ID number

3. Record treatment outcomes at 15- and 60-min ensure source docs are consistent

4. Identify LAR for informed consent approach collect medical hx, home meds, race, ethnicity as needed

5. Complete enrollment CRFs in WebDCU within 8 hours

Study team coverage

• 24-hour study team phone number / pager
• Alert to enrollment occurs immediately after drug is started
• Study team arrival ~30 minutes
• Overnight enrollments may occur
• Site team can decide how to implement KESETT coverage.
• Clinical team
• Conduct opt out if feasible
• Enroll
• Apply Ceribell
• Assess for treatment outcomes at 15-min (continuing seizures, RASS, GCS)

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e-Consent

• RedCap Electronic consent is the prefered way to collect Informed consent forms for SIREN

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• Best for remote verification

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• Site Specific link
• Will include site language
• Will include local HIPAA waivers

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• Part 11 compliant

Follow up

After 24 hours

Check for adverse events - non-serious adverse event are only reported if they occur in the first day

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At participant’s end of study (hospital discharge or 30 days)

Collect serious adverse events and secondary outcomes

Educate, monitor, re-educate

Change of shift

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Simulated mock enrollments

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Academic “detailing”

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Screening

• Patients who meet one of the below criteria:

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• Administered one of the following for the treatment of seizures or status epilepticus
• LEV,
• valproate (valproic acid), or
• fosphenytoin intravenously

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OR

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• Patients in the ED who have had a witnessed seizure and are determined to be experiencing a continuing seizure event who were screened in real time by the study team.

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Screen Failure

Patients that meet the below criteria and were not enrolled regardless of when they were screened and if the study team was present

• Administered one of the following for the treatment of seizures or status epilepticus
• LEV,
• valproate (valproic acid), or
• fosphenytoin intravenously

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• Patients to whom the study team is alerted to in real time but are not enrolled should be entered as screen failures within 5 days of screening.

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• An administrative review should also be performed at least monthly to identify patients who met the criteria above but were not alerted to the study team or enrolled.

Enrollment in WebDCU

DCC Riley Luckmann

KESETT – step forward randomization

• KESETT is a step forward randomization design, which means we do not have a Randomization Form in WebDCU that assigns a treatment when submitted.
• Instead, sites will grab the ‘Use Next’ vial (or ‘Backup’ vial if no ‘Use Next’ is available) and use it to treat the KESETT participant.
• Data entry into WebDCU will occur after enrollment.
• This includes documentation of Study Drug ID, which will tell the DCC which treatment assignment the participant received.
• The KESETT database in WebDCU is a real, live database. No testing or fake data should ever be entered by sites.

Within 8 hours of KESETT study drug administration…

1. Log into WebDCUv2

https://webdcu.musc.edu/DCUApp/Login

2. Click on the KESETT tile

3. Select the Subject Enrollment button from the main menu bar

4. Select ‘Add Record’

5. Enter the Subject Enrollment form and select ‘Save Record’

*As the instructions indicate, Subject Enrollment is irreversible. It should not be data entered until a patient has already received KESETT study drug. In Q20 and Q21, you will have to indicate the Date and time of study drug infusion start.

6. Click the green arrow to go to the Subject CRF Binder

7. Enter and submit other enrollment CRFs

• F501 Rapid EEG
• F502 Study Drug Infusion

F501 Rapid EEG

F502 Study Drug Infusion

F502 Study Drug Infusion