Pediatr Crit Care Me
-
Pediatr Crit Care Me · Jan 2013
Randomized Controlled Trial Multicenter StudyTherapeutic hypothermia after pediatric cardiac arrest trials: the vanguard phase experience and implications for other trials.
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. ⋯ 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.
-
Pediatr Crit Care Me · Jan 2013
Multicenter StudyBrain death in Canadian PICUs: demographics, timing, and irreversibility.
To determine any discordance between first and second brain death examinations and investigate the quality of brain death determination in Canadian PICUs. ⋯ Some brain death diagnoses were not based on two examinations, and some did not include an apnea test. In patients who had two brain death examinations, discordant results were uncommon.