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NCT00878644 · ClinicalTrials.gov registry record · Phase 3

Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial

A Phase 3 study, sponsored by University of Michigan.

Completed
Registry status
Phase 3
Development phase
295
Enrollment target

NCT00878644: Completed Phase 3 study, sponsored by University of Michigan.

NCT00878644 is a Phase 3 study that has completed, run by University of Michigan. The registered enrollment target is 295 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00878644, a Phase 3 study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
Phase 3
Development phase
295 participants
Enrollment target

Study Summary

Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while out of the hospital.

Primary Outcome

Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest.

Interventions

  • PROCEDURE Therapeutic Hypothermia
  • OTHER Therapeutic Normothermia

Trial Details

FieldValue
Enrollment Target 295 participants
Start Date 2009-09
Est. Completion 2014-06
Phase Phase 3
University of Michigan

1,327 total trials

What the finished NCT00878644 record still lists

NCT00878644 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Therapeutic Hypothermia is the first listed.

NCT00878644 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00878644 about?

NCT00878644 is a clinical study titled "Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial". Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluat...

What is the current status of trial NCT00878644?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 295 participants. The study started on 2009-09. Estimated completion is 2014-06.

What interventions are being tested in trial NCT00878644?

The interventions under investigation include: Therapeutic Hypothermia (PROCEDURE), Therapeutic Normothermia (OTHER).

Who is sponsoring clinical trial NCT00878644?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00878644's enrollment target sits among peer trials

295 1166th of 2000 higher than 835 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00878644, the US trial registry maintained by the National Library of Medicine. NCT00878644 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.