ICECAP
Neurological death and disability are common outcomes in survivors of cardiac arrest. Therapeutic cooling of comatose patients resuscitated from shockable rhythms markedly increases the rate of good neurological outcome, but poor outcomes still occur in as many as 50%, and the benefit of cooling in those resuscitated from asystole and pulseless electrical activity has not been shown in a randomized study.
The Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP) study will enroll comatose adult survivors of out of hospital cardiac arrest that have already been rapidly cooled using a definitive temperature control method. Those with and without initial shockable rhythms will be studied as distinct populations (maximum of 1800 subjects over four years). ICECAP will determine if identifying an optimal duration of cooling can improve outcomes, and if development of a duration response curve can substantiate efficacy in a wider patient population
Learn more at: https://siren.network/clinical-trials/icecap
HOBIT
There continues to be an overarching problem of high mortality and poor outcome for victims of severe traumatic brain injury (TBI). Preclinical and clinical investigations indicate that hyperbaric oxygen (HBO2) has a positive impact on reducing brain injury and improving outcomes in severe TBI. By markedly increasing oxygen (O2) delivery to the traumatized brain, HBO2 can reverse the lack of O2 that precipitates cellular energy failure and subsequent brain cell death. In past clinical investigations, HBO2 in comparison to standard care has significantly improved energy production in the brain and improved clinical outcome. However, prior to a formal phase III definitive efficacy study, important information is required regarding optimizing the HBO2 treatment schedule to be instituted in terms of pressure and frequency and other parameters. The lungs in severe TBI patients have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to O2 toxicity. It is essential to determine the most effective HBO2 dose schedule without producing O2 toxicity and clinical complications.
Hyperbaric Oxygen Brain Injury Treatment Trial (HOBIT) is a proposed adaptive clinical trial designed to answer these questions and to provide important data to plan a definitive phase III efficacy trial. Primary aims of this trial are to select, patients with severe TBI, the combination of HBO2 treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Also, the trial will determine, patients with severe TBI, whether there is a > 50% probability of HBO2 treatment demonstrating improvement in the outcome of severe TBI in a subsequent confirmatory phase III trial. This trial will enroll 200 subjects over 3 1/2 years. This trial is supported and sponsored by the SIREN-NETT Network which is funded by the National Institutes of Neurologic Disease and Stroke to conduct clinical trials such as the one described.
Learn more at: https://siren.network/clinical-trials/hobit
BOOST
Traumatic brain injury (TBI) is a major cause of death and disability in developed societies. Every year, approximately 3.5 million Americans sustain a TBI, of which 50,000 die, and another 300,000 are hospitalized and survive the injury. BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.
Learn more at: https://siren.network/clinical-trials/boost-3