Theodore Wu, M.D.

Federal

Funding Agency NATIONAL HEART, LUNG, AND BLOOD INSTITUTE Title Therapeutic Hypothermia After Pediatric Cardiac Arrest `THAPCA? Trials - Scientific Application Status Active Period 2/2011 - Present Role Co-Investigator Grant Detail THAPCA is the Therapeutic Hypothermia After Pediatric Cardiac Arrest Trial. It is a multi-site prospective randomized controlled trial of therapeutic hypothermia after cardiac arrest in children and will be analyzed as an `intention to treat study?. The trial will consist of two sub-studies, one sub-study for out-of-hospital cardiac arrests and the other sub-study for in-hospital cardiac arrests. Patients will be randomly assigned in a 1:1 ratio to receive either therapeutic hypothermia or normothermia within six hours of their cardiac arrest episode. The study design will also include follow-up at 3-months post arrest and 12-16 months post arrest.
Consortium Site PI will be familiar with the study protocol and manual of operations (MOO) for the trial work. This individual will work closely with the research coordinator (nurse) to coordinate and supervise all of the site specific details needed for the THAPCA Trials including IRB approvals, case screening, enrollment, study related intervention and monitoring patient, and data collection and transmission to the DCC. He/She will remain available throughout the conduct of the trial to support the site research coordinator (nurse) and to answer questions about the study protocol of the clinical care team and others. He/she will identify any issues that arise related to conduct of the study, and refer questions to the study THAPCA Executive Committee, DCC or study PI as needed. He/She will participate in study training sessions and all steering committee meetings in person or by conference call. Each site PI will identify a study neurologist and pediatric psychologist to perform study follow up assessments and provide this information to the DCC or study PI.