Therapeutic hypothermia after pediatric cardiac arrest trials: the vanguard phase experience and implications for other trials
| Autor: | Victoria L. Pemberton, Frank W. Moler, Angie Webster, J. Michael Dean, Brittan Browning |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Time Factors medicine.medical_treatment Pilot Projects Critical Care and Intensive Care Medicine Intensive Care Units Pediatric Phase (combat) Hypothermia induced Article Patient safety Clinical Protocols Hypothermia Induced Intensive care medicine Vanguard Humans Parental Consent Cardiopulmonary resuscitation Intensive care medicine Randomized Controlled Trials as Topic business.industry Patient Selection Hypothermia Heart Arrest Pediatrics Perinatology and Child Health medicine.symptom Parental consent business |
| Zdroj: | Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. 14(1) |
| ISSN: | 1529-7535 |
| Popis: | To determine whether an 18-month vanguard phase, in the Therapeutic Hypothermia after Pediatric Cardiac Arrest trials, confirmed study feasibility and patient safety, a prerequisite to continued funding by the sponsor.Randomized controlled trial.Pediatric intensive care and pediatric cardiac care units in 15 clinical sites in the United States and Canada.Children aged 48 hrs to 18 yrs of age, with return of circulation after cardiac arrest.Therapeutic hypothermia vs. therapeutic normothermia.The first 15 of 20 potential sites to obtain Institutional Review Board and subcontract approvals were selected as vanguard sites. Institutional Review Board approvals were obtained 92 days (median, interquartile range 65-114) and subcontracts signed 34 days (interquartile range 20-48) after distribution. Sites screened subjects at 13 days (interquartile range 9-21) and enrolled the first subjects 64 days (interquartile range 13-154) after study launch. The recruitment milestone was reached 4 months ahead of schedule, with no safety concerns identified. Overall recruitment in this ongoing trial remains on target.The Therapeutic Hypothermia after Pediatric Cardiac Arrest vanguard phase proved beneficial for the investigators and funding agency. Because complex multicenter trials are rarely ready to launch when grant funds are received, the vanguard allowed time to refine the protocol and recruitment approaches. Competition for vanguard positions led to expedient Institutional Review Board and subcontract completion. Early success and sustained momentum contributed to recruitment at or above goals. Financial risks to the sponsor were minimized by tying funding for the full trial to achieving prespecified milestones. A vanguard phase may be a desirable strategy for the successful conduct of other complex clinical trials. |
| Databáze: | OpenAIRE |
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