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

• ClinicalTrials.gov Identifier: NCT04217551
• Recruitment Status: Recruiting
• First Posted: January 3, 2020
• Last Update Posted: May 9, 2023
• Sponsor: University of Michigan
• Collaborators: Johns Hopkins University; Medical University of South Carolina; National Institutes of Health (NIH); National Institute of Neurological Disorders and Stroke (NINDS)
• Information provided by (Responsible Party): William J Meurer, University of Michigan

Study Description

Brief Summary:

A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.

Condition or disease	Intervention/treatment	Phase
Cardiac Arrest, Out-Of-Hospital; Hypothermia, Induced; Hypoxia-Ischemia, Brain	Device: Therapeutic Hypothermia	Not Applicable

Detailed Description:

A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.

Cardiac arrest is a common and devastating emergency of the heart and the brain. More than 380,000 patients suffer out of hospital cardiac arrest (OHCA) each year in the US. Improvements in cardiac resuscitation (the early links in the "chain of survival" for patients with OHCA) are tempered by our limited ability to resuscitate and protect the brain from global cerebral ischemia.

Neurological death and disability are common outcomes in survivors of cardiac arrest. Therapeutic cooling of comatose patients resuscitated from shockable rhythms markedly increases the rate of good neurological outcome, but poor outcomes still occur in as many as 50%, and the benefit of cooling in those resuscitated from asystole and pulseless electrical activity has not been shown in a randomized study.

Objectives:

The overarching goal of this project is to identify clinical strategies that will increase the number of patients with good neurological recovery from cardiac arrest. We hypothesize that longer durations of cooling may improve either the proportion of patients that attain a good neurological recovery or may result in better recovery among the proportion already categorized as having good outcomes.

Primary Objectives:

A. To determine, in each of two populations of adult comatose survivors of cardiac arrest (those with initial shockable rhythms and those with pulseless electrical activity (PEA)/asystole), the shortest duration of cooling that provides the maximum treatment effect as determined by a weighted 90 day modified Rankin score B. To determine, in each of two populations of adult comatose survivors of cardiac arrest (those with initial shockable rhythms and those with PEA/asystole), whether increasing durations of cooling are associated with better outcomes or recovery implying efficacy of hypothermia to no cooling.

Secondary Objectives:

To characterize the overall safety and adverse events associated with duration of cooling To characterize the effect of duration of cooling on neuropsychological outcomes To characterize the effect of duration of cooling on patient reported quality of life

Design:

This study is a randomized, response-adaptive, duration (dose) finding, comparative effectiveness clinical trial with blinded outcome assessment. The design is based on a statistical model of response as defined by the primary endpoint, a weighted 90-day mRS, across the treatment arms. The design will fit patient outcome data to a duration response model (separately for shockable and non-shockable rhythms), in which the potentially non-linear association between durations of cooling and the primary endpoint are estimated. All conclusions about the treatment arms are based on this model. The functional form of the duration-response model is flexible and able to fit many different shapes for the duration-response curve. Specifically it is parameterized to identify up to two change-points in the treatment effect across arms, allowing it to fit an increasing, decreasing, flat, plateau, or U-shape duration-response curve.

Subjects will initially be equally randomized between 12, 24, and 48 hours of cooling. After the first 200 subjects have been randomized, additional treatment arms between 12 and 48 hours will be opened and patients will be allocated, within each rhythm type, by response adaptive randomization. As the trial continues, shorter and longer duration arms may be opened. Specifically, a 6-hour duration arm will be opened if the emerging duration-response curve from 12 hours is flat. Similarly, a 60-hour or 72-hour duration arm will be opened if the emerging duration response curve shows an increasing treatment benefit through 48 hours.

This trial will have frequent interim analyses to stop the trial early for futility if it is highly likely that no treatment arm offers a greater benefit then the 6-hour duration arm.

Primary Outcome Measure:

The primary outcome measure will be the modified Rankin scale at 90 days after return of spontaneous circulation. The mRS will be analyzed as a weighted score incorporating both the proportion of subjects achieving a good neurological outcome and degree of residual functional impairment among those with good neurological outcomes.

Study Population:

Comatose adult survivors of out of hospital cardiac arrest that have already been rapidly cooled using a definitive temperature control method (endovascular or surface) will be enrolled in the emergency department or intensive care unit. Hub and spoke hospitals from the SIREN network will be enriched with high potential ancillary Hubs. Approximately 50 hospitals are anticipated to each enroll an average of 9 subjects per year.

Randomization:

Central computerized randomization by web-based interface will be used. Subjects will be potentially randomized over the course of the trial to the following possible durations of cooling (in hours): 6, 12, 18, 24, 30, 36, 42, 48, 60, and 72. The first 200 patients will be randomized 1:1:1 to the 12, 24, and 48-hour durations only. After this initial "burn in" period, response adaptive randomization will be used to allocate subjects to durations inclusive of 12 to 48 hours initially, and then subsequently to the 6, 60 or 72 hour durations if specified conditions are met and the emerging duration-response curve suggests that the maximum treatment benefit might be on those durations. The response adaptive randomization probabilities for each arm will be determined separately for the two rhythm type populations. Randomization probabilities will be updated monthly, or approximately every 38 patients based on the expected accrual rate.

Consent:

Eligible patients for this trial will not have capacity to provide informed consent. Written informed consent from a legally authorized representative will be required.

Intervention:

The intervention will be random allocation to duration of cooling after cardiac arrest. Cooling in the study will be by a definitive temperature control method to a target temperature of 33 deg C. Any endovascular or surface cooling system with closed loop feedback will be allowed. Duration of cooling will be measured from the time that cooling with a definitive device is initiated in the hospital. As part of routine medical care, cooling may be initiated by emergency medical service (EMS) or in the emergency department. Eligibility will require that a temperature of <34 degrees C be obtained by 240 minutes after cardiac arrest. After the allocated duration of cooling is completed, controlled rewarming will be performed. Rewarming to a temperature of 36.5 deg C will occur over the shorter of 24 hours or a rewarming period equal to the allocated duration of cooling. Definitive cooling devices may be used for maintenance of normothermia after rewarming is complete. A clinical standardization guideline will be followed to reduce the effects of practice variability. Key physiologic and practice variables will be tracked and compliance with clinical standardization and deviation from physiologic targets reported back to study teams.

Statistical Analysis for the Primary Outcome Measure:

We will model the mean weighted mRS at 90 days across the treatment arms. The weighted mRS incorporates both the proportion of subjects achieving a good neurological outcome and degree of impairment among those with good neurological outcomes. The primary analysis is conducted separately for each rhythm type, allowing for a different treatment effect by rhythm type, and has two components. First, we identify the most likely target duration, where the target duration is the shortest duration that achieves the maximum treatment effect (Objective A). Second, we calculate whether the efficacy of any duration is superior to any shorter duration of cooling indicating a positive duration response (Objective B). Establishing a positive duration response implies confirmation that cooling is effective in improving outcome or recovery versus normothermia, when a normothermia control arm is not clinically acceptable.

A maximal sample size of 1800 subjects enrolled over 4 years (estimated accrual rate of 37.5 subjects/month) is anticipated.

Investigational Device Exemption

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Bayesian Adaptive Design
• Masking: Single (Outcomes Assessor)
• Masking Description: The outcomes assessors will be blinded to the treatment assignment of the participant.
• Primary Purpose: Treatment
• Official Title: Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients - A Multicenter, Randomized, Adaptive Clinical Trial to Identify the Optimal Duration of Induced Hypothermia for Neuroprotection in Comatose Survivors of Cardiac Arrest
• Actual Study Start Date: May 18, 2020
• Estimated Primary Completion Date: July 15, 2025
• Estimated Study Completion Date: August 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: 6 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 12 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 18 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 24 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 30 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 36 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 42 Hours - shockable; Participants with shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 48 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 60 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 72 hours - shockable; Participants with shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 6 hours - non shockable; Participants with non-shockable initial rhythm will be assigned to receive 6 hours of hypothermia with a target of 33 degrees followed by 6 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 12 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 12 hours of hypothermia with a target of 33 degrees followed by 12 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 18 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 18 hours of hypothermia with a target of 33 degrees followed by 18 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 24 hour - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 24 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 30 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 30 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 36 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 36 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 42 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 42 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 48 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 48 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 60 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 60 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
Experimental: 72 hours - non-shockable; Participants with non-shockable initial rhythm will be assigned to receive 72 hours of hypothermia with a target of 33 degrees followed by 24 hours of controlled rewarming.	Device: Therapeutic Hypothermia; Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.

Outcome Measures

Primary Outcome Measures :

1. Weighted Modified Rankin Scale (mRS) [ Time Frame: 90 days after return of spontaneous circulation ]
   The mRS is a 7 level ordinal scale of disability that ranges from 0 (no symptoms at all) to 6 (death). ICECAP uses weighting of mRS states to capture changes in functional status.

Secondary Outcome Measures :

1. All Cause Mortality [ Time Frame: 90 days after return of spontaneous circulation ]
   All patients who are dead at follow up.
2. NIH Toolbox Crystallized Cognition Composite Score [ Time Frame: 90 days after return of spontaneous circulation ]
   Composite T-scores from a subset of study neuropsychological tests evaluating.
3. NIH Toolbox Fluid Cognition Composite Score [ Time Frame: 90 days after return of spontaneous circulation ]
   Composite T-scores from a subset of study neuropsychological tests evaluating cognitive functioning in awake survivors collected on the NIH Toolbox platform. The fluid cognition composite score is more reflective of capacity for new learning and information. processing in novel situations
4. Pneumonia [ Time Frame: 90 days after return of spontaneous circulation ]
   Determined by simplified Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definitions of Ventilator-Associated Event (VAE) or Pneumonia.
5. Other infection [ Time Frame: 90 days after return of spontaneous circulation ]
   Determined by simplified CDC NHSN (Center for Disease Control National Healthcare Safety Network) definitions of Urinary Tract Infection or Blood Stream Infection.
6. Malignant cardiac arrhythmia [ Time Frame: 90 days after return of spontaneous circulation ]
   Defined as any arrhythmia that requires termination with chest compressions, pacing, defibrillation, or electrical cardioversion. Arrhythmias (including atrial fibrillation) managed only with medication are excluded.
7. Seizures [ Time Frame: 90 days after return of spontaneous circulation ]
   Defined as unambiguous convulsive or electroencephalographic seizure activity triggering urgent initial or additional anticonvulsant therapy. This definition does not include those given further anticonvulsants as secondary prophylaxis or as treatment for vague or uncertain exam findings or nondiagnostic electroencephalography. It does not include myoclonus.
8. Neurological worsening [ Time Frame: 90 days after return of spontaneous circulation ]
   Determined by a decrease in Full Outline of Unresponsiveness (FOUR) score of ≥4 points that persists on two consecutive days or is associated with a neurological death. It excludes transient fluctuations in neurological examination or changes attributed to pharmacological sedation or paralysis.
9. Electrolyte abnormalities [ Time Frame: 90 days after return of spontaneous circulation ]
   Defined as a measured serum Na, K, Mg, or Ca that is either higher or lower than study defined boundaries on at least two sequential measurements and resulting in a change in IV therapy. It excludes deliberate hypernatremia or hypermagnesemia induced to treat intracranial hypertension or shivering.
10. Coagulopathies [ Time Frame: 90 days after return of spontaneous circulation ]
    Defined as requiring all 3 of the following parameters: (1) some form of major bleeding associated with (2) laboratory confirmation of an abnormal clotting axis and (3) treatment with blood product transfusion or reversal agent. Laboratory testing may include International Normalized Ratio (INR), partial thromboplastin time (PTT), clotting time, or thromboelastography.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Coma after resuscitation from out of hospital cardiac arrest
• Cooled to <34 deg C with 240 minutes of cardiac arrest
• Definitive temperature control applied
• Age ≥ 18 years
• Informed consent from legal authorized representative (LAR) including intent to maintain life support for 96 hours
• Enrollment within 6 hours of initiation of cooling

Exclusion Criteria:

• Hemodynamic instability
• Pre-existing neurological disability or condition that confounds outcome determination
• Pre-existing terminal illness, unlikely to survive to outcome determination
• Planned early withdrawal of life support
• Presumed sepsis as etiology of arrest
• Prisoner

Contacts and Locations

Contacts

Contact: William Meurer; 734-232-2142; wmeurer@med.umich.edu

Contact: Mickie Speers; 734-232-2142; lraes@med.umich.edu

Locations

United States, Alabama

University of Alabama Hospital; Recruiting

Birmingham, Alabama, United States, 35233

Contact: Michael Kurz

United States, Arizona

Banner University Medical Center; Recruiting

Tucson, Arizona, United States, 85719

Contact: Cameron Hypes

United States, California

Cedars-Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Shahed Toosi

Ronald Regan UCLA Medical Center; Recruiting

Los Angeles, California, United States, 90095

Contact: Richelle Cooper

UC Davis Medical Center; Recruiting

Sacramento, California, United States, 95817

Contact: Matthew Greer

UC San Diego Medical Center - Hillcrest; Recruiting

San Diego, California, United States, 92103

Contact: Gabriel Wardi

Zuckerberg San Francisco General Hospital; Recruiting

San Francisco, California, United States, 94110

Contact: Claude Hemphill

Stanford University Medical Center; Recruiting

Stanford, California, United States, 94305

Contact: Karen Hirsch

Harbor-UCLA Medical Center; Recruiting

Torrance, California, United States, 90502

Contact: Kabir Yadav

United States, Colorado

University of Colorado Hospital; Recruiting

Aurora, Colorado, United States, 80045

Contact: Sarah Perman

Denver Health Medical Center; Recruiting

Denver, Colorado, United States, 80204

Contact: Jason Haukoos

United States, Connecticut

Yale New Haven Hospital; Recruiting

New Haven, Connecticut, United States, 06510

Contact: Charles Wira

United States, Florida

UF Health Shands Hospital; Recruiting

Gainesville, Florida, United States, 32608

Contact: Torben Becker

United States, Georgia

Grady Memorial Hospital; Recruiting

Atlanta, Georgia, United States, 30303

Contact: Andre Holder

United States, Hawaii

The Queen's Medical Center; Recruiting

Honolulu, Hawaii, United States, 96813

Contact: Matthew Koenig

United States, Illinois

Northwestern Memorial Hospital; Recruiting

Chicago, Illinois, United States, 60611

Contact: Peter Pruitt

Rush University Medical Center; Recruiting

Chicago, Illinois, United States, 60612

Contact: Yanina Purim-Shem-Tov

University of Illinois-Chicago Hosptial; Recruiting

Chicago, Illinois, United States, 60612

Contact: Marina Del Rios

University of Chicago Medical Center; Recruiting

Chicago, Illinois, United States, 60637

Contact: David Beiser

Advocate Christ Medical Center; Recruiting

Oak Lawn, Illinois, United States, 60453

Contact: Kenneth Dodd

United States, Indiana

IU Health Methodist Hospital; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Benton Hunter

United States, Kentucky

University of Kentucky Hospital; Recruiting

Lexington, Kentucky, United States, 40536

Contact: Vedant Gupta

United States, Maine

Maine Medical Center; Recruiting

Portland, Maine, United States, 04102

Contact: Teresa May

United States, Maryland

University of Maryland Medical Center; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Neeraj Badjatia

Johns Hopkins Hospital; Recruiting

Baltimore, Maryland, United States, 21287

Contact: Sung-Min Cho

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Michael Silverman

Brigham & Women's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Jong Lee

Beth Israel Deaconess Medical Center; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Michael Donnino

United States, Michigan

University of Michigan Hospital; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Cindy Hsu

Detroit Receiving Hospital; Recruiting

Detroit, Michigan, United States, 48201

Contact: James Paxton

Henry Ford Hospital; Recruiting

Detroit, Michigan, United States, 48202

Contact: Joseph Miller

DMC Sinai Grace Hospital; Recruiting

Detroit, Michigan, United States, 48235

Contact: John Wilburn

Spectrum Health Butterworth Hospital; Recruiting

Grand Rapids, Michigan, United States, 49503

Contact: Joshua Reynolds

William Beaumont Hospital; Recruiting

Royal Oak, Michigan, United States, 48073

Contact: Robert Swor

United States, Minnesota

M Health Fairview Southdale Hospital; Recruiting

Edina, Minnesota, United States, 55435

Contact: Benjamin Miller

Hennepin County Medical Center; Recruiting

Minneapolis, Minnesota, United States, 55415

Contact: Brian Driver

M Health Fairview East Bank Hospital; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Benjamin Miller

Regions Hospital; Recruiting

Saint Paul, Minnesota, United States, 55101

Contact: Kealy Ham

United States, Nebraska

University of Nebraska Medical Center; Recruiting

Omaha, Nebraska, United States, 68198

Contact: Aaron Barksdale

United States, New Jersey

Cooper University Hospital; Recruiting

Camden, New Jersey, United States, 08103

Contact: Hope Kilgannon

United States, New York

Kings County Hospital Center; Recruiting

Brooklyn, New York, United States, 11203

Contact: Izad-Yar Rasheed

NYP Columbia University Medical Center; Recruiting

New York, New York, United States, 10032

Contact: Sachin Agarwal

Strong Memorial Hospital; Recruiting

Rochester, New York, United States, 14642

Contact: Imad Khan

Stony Brook University Hospital; Recruiting

Stony Brook, New York, United States, 11794

Contact: Ethan Brandler

SUNY Upstate Medical University; Recruiting

Syracuse, New York, United States, 13210

Contact: Birendra Sah

United States, North Carolina

Duke University Hospital; Recruiting

Durham, North Carolina, United States, 27710

Contact: Alexander Limkakeng

Wake Forest Baptist Medical Center; Recruiting

Winston-Salem, North Carolina, United States, 27157

Contact: Aarti Sarwal

United States, Ohio

University of Cincinnati; Recruiting

Cincinnati, Ohio, United States, 45220

Contact: Justin Benoit

OSU East Hospital; Recruiting

Columbus, Ohio, United States, 43203

Contact: Richard Gumina

OSU Wexner Medical Center; Recruiting

Columbus, Ohio, United States, 43210

Contact: Jeff Caterino

Mercy St. Vincent Medical Center; Recruiting

Toledo, Ohio, United States, 43608

Contact: David Ledrick

United States, Oregon

Adventist Health; Recruiting

Portland, Oregon, United States, 97216

Contact: Mohamud Daya

United States, Pennsylvania

Geisinger Medical Center; Recruiting

Danville, Pennsylvania, United States, 17822

Contact: Douglas Kupas

UPMC Harrisburg; Recruiting

Harrisburg, Pennsylvania, United States, 17101

Contact: Erik Kochert

Hospital of the University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Benjamin Abella

Penn Presbyterian Medical Center; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Benjamin Abella

Thomas Jefferson University Hospital; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contact: David Gaieski

Temple University Hospital; Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contact: Nina Gentile

University of Pittsburgh Medical Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Johnathan Elmer

Guthrie Robert Packer Hospital; Recruiting

Sayre, Pennsylvania, United States, 18840

Contact: Jon Rittenberger

United States, Texas

Parkland Hospital; Recruiting

Dallas, Texas, United States, 75235

Contact: Ava Pierce

Memorial Hermann Hospital; Recruiting

Houston, Texas, United States, 77030

Contact: Elizabeth Jones

United States, Utah

University of Utah Hospital; Recruiting

Salt Lake City, Utah, United States, 84132

Contact: Joseph Tonna

United States, Virginia

University of Virginia Medical Center; Recruiting

Charlottesville, Virginia, United States, 22903

Contact: Robert O'Connor

VCU Medical Center; Recruiting

Richmond, Virginia, United States, 23298

Contact: Mary Ann Peberdy

United States, Washington

Harborview Medical Center; Recruiting

Seattle, Washington, United States, 98104

Contact: Nick Johnson

United States, Wisconsin

Froedtert Hospital; Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Tom Aufderheide

Sponsors and Collaborators

University of Michigan

Johns Hopkins University

Medical University of South Carolina

National Institutes of Health (NIH)

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

• Principal Investigator: William Meurer; University of Michigan
• Principal Investigator: Robert Silbergleit; University of Michigan
• Principal Investigator: Romer Geocadin; Johns Hopkins University

  Study Documents (Full-Text)

Documents provided by William J Meurer, University of Michigan:

Study Protocol  [PDF] May 4, 2020

Informed Consent Form  [PDF] May 4, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen CT, Lin JW, Wu CH, Kuo RN, Shih CH, Hou PC, Yen DH, How CK. A Simple Risk Score for Predicting Neurologic Outcome in Out-of-Hospital Cardiac Arrest Patients After Targeted Temperature Management. Crit Care Med. 2022 Mar 1;50(3):428-439. doi: 10.1097/CCM.0000000000005266.

• Responsible Party: William J Meurer, Associate Professor of Emergency Medicine and Neurology, University of Michigan
• ClinicalTrials.gov Identifier: NCT04217551
• Other Study ID Numbers: G160072; U01NS073476 ( U.S. NIH Grant/Contract )
• First Posted: January 3, 2020
• Last Update Posted: May 9, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data will be stored in the NHLBI data repository after trial completion.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: 1 year after publication on main outcome results paper
• Access Criteria: Data use agreement with the appropriate NHLBI repository

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by William J Meurer, University of Michigan:

Bayesian Adaptive Clinical Trial; Hypothermia, therapeutic; Coma

Additional relevant MeSH terms:

Brain Ischemia; Hypoxia-Ischemia, Brain; Heart Arrest; Out-of-Hospital Cardiac Arrest; Ischemia; Hypoxia; Hypothermia; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Body Temperature Changes; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Hypoxia, Brain