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Cardiac Arrest, Out-Of-HospitalNCT05376267

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

A study testing Therapeutic Hypothermia in people with Cardiac Arrest, Out-Of-Hospital and Hypothermia, Induced, run by University of Michigan at 65 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. Read more about this study

Who is it for?
Ages 2 days to 17 years
What is being tested?
Therapeutic Hypothermia
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
65 sitesin 5 countries
Study dates
5 Aug 2022to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 days to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 2 days to < 18 years with corrected gestational age of at least 38 weeks
  • Chest compressions for at least 2 minutes
  • Coma or encephalopathy after resuscitation from Out-of-Hospital Cardiac Arrest (OHCA)
  • Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
  • Definitive temperature control device initiated
  • Randomization within 6 hours of Return of Spontaneous Circulation (ROSC)
  • Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours

Who cannot join

  • Glasgow Coma Motor Score (GCMS) = 6
  • LAR does not speak English or Spanish
  • Duration of Cardiopulmonary Resuscitation (CPR) > 60 minutes
  • Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO)
  • Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy
  • Pre-existing terminal illness, unlikely to survive to one year
Show all 19Show fewer
  • Cardiac arrest associated with brain, thoracic, or abdominal trauma
  • Active and refractory severe bleeding prior to randomization
  • Extensive burns or skin lesions incompatible with surface cooling
  • Planned early withdrawal of life support before 120 hours
  • Sickle cell anemia
  • Pre-existing cryoglobulinemia
  • Non-fatal drowning in ice covered water
  • Central nervous system tumor with ongoing chemotherapy
  • Previous enrollment in P-ICECAP trial
  • Prisoner
  • Chronic hypothermia
  • New post-cardiac arrest diabetes insipidus
  • Pregnancy

Trial locations and contacts

65 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Frank Moler, MD contact

734-764-5302

fmoler@umich.edu

Moni Weber contact

734-232-4803

monij@umich.edu

65 sites in 5 countries

United States52 sites, 49 recruiting

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

    Ryan Nofziger, MD, 330-543-8639, mofziger@akronchildrens.org

    Chris Page-Goertz, MD, 330-543-8639, cpage-goertz@akronchildrens.org

    Recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Ilana Harwayne-Gidansky, MD, 5182625127, harwayi@amc.edu

    Ilana Harwayne-Gidansky, MD

    Recruiting

  • University of Michigan CS Mott Children's Hospital

    Ann Arbor, Michigan, 48109

    Ryan Barbaro, MD, barbaror@umich.edu

    Ryan Barbaro, MD

    Recruiting

  • University of Maryland Children's Hospital

    Baltimore, Maryland, 21201

    Siddhartha Dante, MD, abhutta@som.umaryland.edu

    Siddhartha Dante, MD

    Recruiting

  • Johns Hopkins Medicine Children's Center

    Baltimore, Maryland, 21287

    Caitlin O'Brien, MD, MPH, 720-635-1730, Cobrie19@jhmi.edu

    Caitlin O'Brien, MD, MPH

    Recruiting

  • University of Alabama at Birmingham / Children's of Alabama

    Birmingham, Alabama, 35233

    Michele Kong, MD, 205-638-9387, mkong@uabmc.edu

    Michele Kong, MD

    Recruiting

  • MassGeneral Hospital for Children

    Boston, Massachusetts, 02114

    Sarah MD Murphy, MD, 617-724-4380, samurphy@mgh.harvard.edu

    Sarah Murphy, MD

    Recruiting

  • University of Buffalo / Oishei Children's Hospital

    Buffalo, New York, 14203

    Ryan Breuer, MD, ryanbrue@buffalo.edu

    Ryan Breuer, MD

    Recruiting

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7220

    Kieran Leong, DO, 919-966-7495, Kieran_Leong@med.unc.edu

    Benny Joyner, MD, MPH

    Recruiting

  • Ann & Robert Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Craig Smith, MD, 312-227-4800, CMSmith@luriechildrens.org

    Craig Smith, MD

    Recruiting

  • Comer Children's Hospital, University of Chicago

    Chicago, Illinois, 60637

    Casey Stulce, MD, 7738343837, cstulce@bsd.uchicago.edu

    Casey Stulce, MD

    Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

    Ranjit Chima, MD, ranjit.chima@cchmc.org

    Ranjit Chima, MD

    Recruiting

  • Ohio State University / Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Marlina Lovett, MD, marlina.lovett@nationwidechildrens.org

    Marlina Lovett, MD

    Recruiting

  • Medical City Children's Hospital

    Dallas, Texas, 75230

    G. Kris Bysani, M.D. MS, FAAP, FCCM, 972 566 8340, kbysani@pacant.com

    G. Kris Bysani, M.D. MS, FAAP, FCCM

    Recruiting

  • Children's Medical Center of Dallas

    Dallas, Texas, 75235

    Joshua Wolovits, MD, joshua.wolovits@utsouthwestern.edu

    Joshua Wolovits, MD

    Recruiting

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

    Hemanth Lingadevaru, MD, 9376415168, lingadevaruh@childrensdayton.org

    Hemanth Lingadevaru, MD

    Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Kathleen Meert, MD, 313-745-5870, meert1kl@cmich.edu

    Kathleen Meert, MD

    Recruiting

  • University of Florida (UF) Health Shands Children's Hospital

    Gainesville, Florida, 32610-0296

    Shruthi Mahadevaiah, MD, 313-318-7383, smahadevaiah@ufl.edu

    Shruthi Mahadevaiah, MD

    Recruiting

  • Penn State University / Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

    Neal Thomas, MD, nthomas@pennstatehealth.psu.edu

    Neal Thomas, MD

    Recruiting

  • Children's Memorial Hermann Hospital

    Houston, Texas, 77030

    Thao Nguyen, MD, 832 512 1595, Thao.L.Nguyen@uth.tmc.edu

    Recruiting

  • Texas Children's Hospital, Baylor

    Houston, Texas, 77030

    Jennifer Erklauer, MD, jclee@bcm.edu

    Jennifer Erklauer, MD

    Recruiting

  • Riley Children's Health

    Indianapolis, Indiana, 46202

    Matthew Yuknis, MD, 317-944-3345, myuknis@iupui.edu

    Matthew Yuknis, MD

    Recruiting

  • University of Iowa, Carver College of Medicine

    Iowa City, Iowa, 52242

    Kari Wellnitz, MD, kari-wellnitz@uiowa.edu

    Kari Wellnitz, MD

    Recruiting

  • Memorial Health - Miller Children's and Women's Hospital of Long Beach

    Long Beach, California, 90806-1701

    Christopher Babbitt, MD, 562-933-8743, CBabbitt@memorialcare.org

    Christopher Babbitt, MD

    Recruiting

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

    Bradley De Souza, MD, 323-361-8202, bdesouza@chla.usc.edu

    David Baron, MS, 323-361-6329, dbaron@chla.usc.edu

    Recruiting

  • University of California Los Angeles (UCLA) Mattel Children's Hospital

    Los Angeles, California, 90095

    Anil Sapru, MD, asapru@mednet.ucla.edu

    Anil Sapru, MD

    Recruiting

  • American Family Children's Hospital

    Madison, Wisconsin, 53705

    Peter Ferrazzano, MD, (608) 265-4839, ferrazzano@pediatrics.wisc.edu

    Peter Ferrazzano, MD

    Recruiting

  • University of Tennesses Health Center / Le Bonheur Children's

    Memphis, Tennessee, 38104

    Laurel Metzler, MD, lmetzler@uthsc.edu

    Laruel Metzler, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33124

    Jennifer Munoz Pareja, MD, jcm457@med.miami.edu

    Jennifer Munoz Pareja, MD

    Recruiting

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226

    Binod Balakrishnan, MD, 414-266-3360, bbalakris@mcw.edu

    Binod Balakrishnan, MD

    Recruiting

  • University of Minnesota Fairview Masonic Children's Hospital

    Minneapolis, Minnesota, 55454

    Withdrawn

  • J.W. Ruby Memorial Hospital

    Morgantown, West Virginia, 26506

    Ryan A Nofziger, MD, MBA, 304-293-1217, Ryan.Nofziger@hsc.wvu.edu

    Ryan A Nofziger, MD, MBA

    Recruiting

  • Cohen Children's Medical Center of NY / Northwell Health

    New Hyde Park, New York, 11040

    Taylor Nickerson, MD, (718) 470-3668, tnickerson@northwell.edu

    Todd Sweberg, MD

    Recruiting

  • Mount Sinai Icahn / Kravis Children's Hospital

    New York, New York, 10029

    Shubhi Kaushik, MD

    Shubhi Kaushik, MD

    Recruiting

  • University of California - Oakland / UCSF Benoiff Children's Hospital Oakland

    Oakland, California, 94609

    Natalie Cvijanovich, MD, (510) 428-3302

    Natalie Cvijanovich, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68114

    Alyson Baker, MD MS, 402-955-7257, alybaker@childrensnebraska.org

    Alyson Baker, MD MS

    Recruiting

  • Children's Hospital of Orange County

    Orange, California, 92868-4203

    Adam Schwarz, MD, 714-509-8620, aschwarz@choc.org

    Adam Schwarz, MD

    Recruiting

  • Children's Hospital of Illinois

    Peoria, Illinois, 61637

    Sandeep Tripathi, MD, 309-624-0719, sandeept@uic.edu

    Sandeep Tripathi, MD

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Matthew Kirschen, MD, kirschenm@chop.edu

    Matthew Kirschen, MD

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    F. Anthony Willyerd, MD, 602-471-5064, fwillyerd@phoenixchildrens.com

    F. Anthony Willyerd, MD

    Recruiting

  • Children's Hospital of Pittsburgh (UPMC)

    Pittsburgh, Pennsylvania, 15224

    Ericka Fink, MD, finkel@ccm.upmc.edu

    Ericka Fink, MD

    Recruiting

  • Oregon Health & Science University Doernbecher Children's Hospital

    Portland, Oregon, 97239

    Mohamud Daya, MD, MS, 503-494-7248, dayam@ohsu.edu

    Serena Kelly, MS, 503-789-4580, phromsiv@ohsu.edu

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642-8667

    Jake Deines, MD, 585-273-5269, Jake_deines@urmc.rochester.edu

    Jake Deines, MD

    Recruiting

  • University of California, Davis

    Sacramento, California, 95817

    Heather Siefkes, MD, 916-734-7620, hsiefkes@ucdavis.edu

    Heather Siefkes, MD

    Recruiting

  • Primary Children's Hospital, University of Utah School of Medicine

    Salt Lake City, Utah, 84108

    Withdrawn

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Theodore Wu, MD, 210-567-5816, wut@uthscsa.edu

    Theodore Wu, MD

    Recruiting

  • University of California - San Francisco (UCSF) Benioff Children's Hospital San Francisco

    San Francisco, California, 94158

    Patrick McQuillen, MD, patrick.mcquillen@ucsf.edu

    Patrick McQuillen, MD

    Recruiting

  • Stanford

    Santa Clara, California, 95050

    Tim Cornell, MD, tcornell@stanford.edu

    Tim Cornell, MD

    Recruiting

  • Washington University / St. Louis Children's Hospital

    St Louis, Missouri, 63110

    Stuart Friess, MD, friess@wustl.edu

    Stuart Friess, MD

    Recruiting

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

    Anthony Sochet, MD., M.Sc., 727-767-4343, asochet1@jh.edu

    Nathan Dean, MD

    Recruiting

  • Montefiore Einstein Hospital Moses Campus

    The Bronx, New York, 10467

    Alvaro J Coronado Munoz, MD, 7187412432, acoronadom@montefiore.org

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Completed

Other trials in United States

Australia7 sites, 7 recruiting

  • Queensland Children's Hospital

    Brisbane, Queensland, 4101

    Adrian Mattke, MD, PhD, FRACP, FCICM, +61 (4) 0169 8994, Adrian.Mattke@health.qld.gov.au

    Tara Williams, MSN, Tara.Williams@health.qld.gov.au

    Recruiting

  • Monash Medical Centre

    Clayton, Victoria, 3168

    Meredith Allen, MB.BS, FRACP, meredith.allen@monashhealth.org

    Meredith Allen, MB.BS, FRACP

    Recruiting

  • Townsville University Hospital

    Douglas, Queensland

    Andrew Clift, FCICM, FACRRM, GMC, Andrew.Clift@health.qld.gov.au

    Andrew Clift, FCICM, FACRRM, GMC

    Recruiting

  • Perth Children's Hospital

    Nedlands, Western Australia

    Simon Erikson, FRACP, 61 (8) 6456 4437, simon.erickson@health.wa.gov.au

    Jenipher Chumbres Flores, MSN, Jenipher.ChumbesFlores@health.wa.gov.au

    Recruiting

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

    Subdodh Ganu, MBBS, MD, FCICM, 61 8 8161 6881, subodh.ganu@sa.gov.au

    Subdodh Ganu, MBBS, MD, FCICM

    Recruiting

  • Royal Children's Hospital

    Parkville, Victoria, 3052

    Warrick Butt, FELSO, FCICM, MBBS, 61 (4) 0777 6886, Warwick.Butt@rch.org.au

    Warrick Butt, FELSO, FCICM, MBBS

    Recruiting

  • Gold Coast University Hospital

    Southport, Queensland

    Shane George, BSc MBBS MPH FACEM, +61 (4) 0169 8994, shane.george@uq.edu.au

    Tara Williams, MSN, Tara.Williams@health.qld.gov.au

    Recruiting

Other trials in Australia

United Kingdom4 sites, 4 recruiting

  • Birmingham Children's Hospital, United Kingdom

    Birmingham

    Hari Krishnan, MD, hari.krishnan2@nhs.net

    Hari Krishnan, MD

    Recruiting

  • Bristol Royal Hospital for Children

    Bristol, Bristol, BS2 8BJ

    Omar Aziz, MSC, MRCGP, MRCPCH, DGM, 44 3788956254, Omer.Aziz@uhbw.nhs.uk

    Omar Aziz, MSC, MRCGP, MRCPCH, DGM

    Recruiting

  • Leeds Children's Hospital

    Leeds, LS1 3EX

    Jo Lumsden, MBBCh, 44 113 392 8458 ext. 7447, jolumsden@nhs.net

    Jo Lumsden, MBBCh

    Recruiting

  • Evelina London Children's Hospital

    London, London, SE17EH

    Andrew Nyman, MBBCh, 44 7825658012, Andrew.Nyman@gstt.nhs.uk

    Andrew Nyman, MBBCh

    Recruiting

Other trials in United Kingdom

Canada1 site, 1 recruiting

  • The Hospital for Sick Children

    Toronto, Ontario

    Anne-Marie Guerguerian, MD, PhD, 416-813-7654, anne-marie.guerguerian@sickkids.ca

    Anne-Marie Guerguerian, MD, PhD

    Recruiting

Other trials in Canada

New Zealand1 site, 1 recruiting

  • Starship Children's Hospital

    Grafton, Auckland, 1142

    John S Beca, FRACP, FCICM, JohnBeca@adhb.govt.nz

    John Beca, FRACP, FCICM

    Recruiting

Other trials in New Zealand

About this study

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest.

The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.

Being tested
Therapeutic Hypothermia
Keywords
Bayesian Adaptive Clinical Trial, Hypothermia, therapeutic, Coma, Pediatric
Medical subject headings
Out-of-Hospital Cardiac Arrest, Hypothermia, Hypoxia-Ischemia, Brain, Coma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic HypothermiaDevice

    Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming,

    A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations. Alternatively, longer durations (84 or 96 hours) will be opened for enrollment if the treatment effects are increasing (rather than plateauing or decreasing) through 72 hours.

Study groups in NCT05376267
Study groupRoleWhat they receive
Cooling 0 hoursExperimentalParticipants will be kept at a normal temperature for the whole 5 days.
Receives: Device: Therapeutic Hypothermia
Cooling 12 hoursExperimentalThe participant will be cooled to 33°Celsius (C) for 12 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 18 hoursExperimentalThe participant will be cooled to 33°C for 18 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 24 hoursExperimentalThe participant will be cooled to 33°C for 24 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 36 hoursExperimentalThe participant will be cooled to 33°C for 36 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 48 hoursExperimentalThe participant will be cooled to 33°C for 48 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 60 hoursExperimentalThe participant will be cooled to 33°C for 60 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 72 hoursExperimentalThe participant will be cooled to 33°C for 72 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 84 hoursExperimentalThe participant will be cooled to 33°C for 84 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia
Cooling 96 hoursExperimentalThe participant will be cooled to 33°C for 96 hours, slowly rewarmed over approximately 16 hours, and then will be kept at a normal temperature (36.8°C or 98.6°F) until the end of the 5th day.
Receives: Device: Therapeutic Hypothermia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation

    The VABS-3 score, designed to be administered to surviving children with any level of function including comatose status to age-appropriate neurobehavioral functioning, ranges from 20 to 140 with age-corrected standardized mean and standard deviation of 100 and 15, respectively. Deaths will be scored as 0 in this trial.

    Measured: 12 months after out-of-hospital cardiac arrest

Secondary outcomes (3)

  1. Change in Pediatric Cerebral Performance Category (PCPC) at 12 months from baseline

    The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.

    Measured: Baseline and 12 months after cardiac arrest

  2. Pediatric Resuscitation after Cardiac Arrest (PRCA) at 12 months

    The PRCA adapted from the Pediatric Stroke Outcome measure, ranges from 0-21 where lower scores indicate less impairment. Deaths will be assigned the worst score of 21 for PRCA.

    Measured: 12 months after cardiac arrest

  3. Survival at 12 months

    Measured: 12 months after cardiac arrest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start5 Aug 2022
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Bayesian Adaptive Design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05376267
Sponsor's protocol ID
IDE G210126
Other IDs
1UG3HL159134-01, U24HL159132, HUM00206424
Status last verified
Oct 2026
First submitted
11 May 2022
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The data will be stored in the NHLBI data repository after trial completion.

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Hypothermia in people with Cardiac Arrest, Out-Of-Hospital and Hypothermia, Induced, run by University of Michigan at 65 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Australia, United Kingdom, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frank Moler, MD (734-764-5302, fmoler@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vineland Adaptive Behavior Scales - Third Edition (VABS-3) Mortality Composite Score at 12 months after return of spontaneous circulation (time frame: 12 months after out-of-hospital cardiac arrest). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05376267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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