1/2 pediatric influence of cooling duration on efficacy in cardiac arrest patients (p-icecap)

Active Cooperative Agreement Awarded Last action

Award ID
UH3HL159134
Recipient
Awarding agency
Obligated
$17,343,616

Award facts

Completion date 73% complete
Funding agency
National Institute of Neurological Disorders and Stroke National Institutes of Health, Department of Health and Human Services
Place of performance
Ann Arbor, MI 48109, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Out-of-hospital cardiac arrest (ohca) in children is a tragic event that usually results in death or permanent brain injury in survivors. More than 7000 children suffer ohca each year in the US and improvements in pediatric ohca outcomes, just as in adults, is very much limited by our ability to protect the brain from global cerebral ischemic injury in those who are successfully resuscitated. Targeted temperature management (TTM) is currently guideline-recommended in children following ohca with preference stated for therapeutic hypothermia (TTM 32-34°c) over normothermia (TTM 36-37.5°c) in order to prevent fever which could amplify brain injury. The optimal duration and patient selection criteria for therapeutic hypothermia in children remain unknown and cooling devices are not specifically FDA approved for this indication. Preclinical data and mechanistic studies strongly suggest that durations of hypothermia longer than those typically used in adults may minimize brain injury. This study will determine if identifying an optimal duration (dose) of therapeutic hypothermia can improve outcomes, and if development of a duration response curve can confirm efficacy in a wider pediatric population of ohca survivors. We hypothesize that longer durations of cooling will improve survival and result in better neurologic recovery in survivors compared to shorter cooling durations, as assessed by the vineland adaptive behavior scales-third edition (vineland-3) score. The primary goal of this project is to identify clinical strategies that will increase the number of patients with improved neurological recovery from ohca. The results of this trial will be extremely significant in children and will immediately impact both clinical practice and regulatory evaluation. The pediatric influence of cooling duration on efficacy in cardiac arrest patients (p-icecap) trial, modeled after the ongoing adult icecap trial, uses innovative adaptive dose finding methods that allow exploration of a wide range of potential durations and efficiently allocate subjects where they will be most informative. The study will be conducted using resources of the nhlbi/ninds strategies to innovate emergency care clinical trials network (siren), which is experienced in both pediatric and adult trials, and is currently conducting the current adult icecap trial. Siren leverages existing resources to achieve economies of scale and to conduct important clinical investigations spanning from pre-hospital, through both the emergency department and ICU stay, and post hospital discharge.

Transactions

Action Obligated Date
Amendment $0
Amendment $0
Amendment $996,426
Amendment $996,426
Amendment $996,426
Amendment $993,773
Amendment $3,110,233
Amendment $1,441,512
Amendment $1,441,512
Amendment $870,084
Amendment $3,248,612
Original award $3,248,612
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Subawards

Subrecipient Amount Awarded
Foundation For Pediatric Acute Care And Quality P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $37,138
All Childrens Research Institute Inc. $37,138
Albany Medical College $37,138
Albert Einstein College Of Medicine $37,138
Board Of Regents Of The University Of Nebraska $37,138
Birmingham Women's And Children's NHS Foundation Trust $56,138
Central Michigan University As a Co-investigator, Dr. Meert will perform similar work as she performed in the THAPCA study. She has collaborated very closely with Dr. Moler since 2002… $118,279
Saint Louis University P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $37,138
University Of Texas Health Science Center At Houston $37,138
University Of Arizona $74,276
Icahn School Of Medicine At Mount Sinai P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
University Of Rochester $74,276
Geisinger Clinic $37,138
University Of Pittsburgh - Of The Commonwealth System Of Higher Education Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) Trial P-ICECAP is the Pediatric Influence of Cooling duration on… $74,276
University Of California, Davis $74,276
The Medical College Of Wisconsin, Inc. $74,276
Children's Hospital Medical Center Of Akron P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
The Johns Hopkins University $74,276
The University Of Texas Health Science Center At San Antonio $408,276
University Of California, LOS Angeles $74,276
The University Of Texas Southwestern Medical Center $74,276
ANN & Robert H Lurie Childrens Hospital Of Chicago ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
University Of Illinois P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
The General Hospital Corporation $74,276
University Of Miami $74,276
Childrens Hospital Medical Center Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) Trial P-ICECAP is the Pediatric Influence of Cooling duration on… $74,276
University Of Tennessee P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
Phoenix Children's Hospital, Inc. Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (P-ICECAP) Trial P-ICECAP is the Pediatric Influence of Cooling duration on… $37,138
University Of Wisconsin System P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
Research Institute At Nationwide Children's Hospital $74,276
Hugo W. Moser Research Institute At Kennedy Krieger, Inc. As the site principal investigator for the Kennedy Krieger Institute (KKI), Dr. Beth Slomine will be familiar with the study protocol and manual of procedures… $413,866
The Research Foundation For The State University Of New York P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
University Of Maryland, Baltimore $74,276
University Of North Carolina At Chapel Hill $74,276
Pennsylvania State University $74,276
Dayton Childrens Hospital $74,276
The University Of Iowa $74,276
The Feinstein Institutes For Medical Research $74,276
Memorial Health Services $74,276
The Regents Of The University Of California. San Francisco $74,276
The University Of Chicago $74,276
Central Michigan University $74,276
The Hospital For Sick Children $74,276
University Of Florida $74,276
Griffith University ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $76,274
The Washington University $74,276
University Of Utah P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $37,138
Children's Hospital LOS Angeles ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
University Of Alabama At Birmingham P-ICECAP is the Pediatric Influence of Cooling duration on Efficacy in Cardiac Arrest Patients Trial. It is a multi-site prospective randomized controlled trial… $74,276
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Quick answers

Who received award UH3HL159134?

UH3HL159134 was awarded to Regents Of The University Of Michigan by National Heart Lung and Blood Institute (National Institutes of Health) on September 15, 2021.

How much is award UH3HL159134 worth?

$17,343,616 has been obligated on UH3HL159134.

Which agency awarded UH3HL159134?

National Heart Lung and Blood Institute (National Institutes of Health) awarded UH3HL159134, with funding from National Institute of Neurological Disorders and Stroke (National Institutes of Health).

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