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Clinical Trials

ICECAP: Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.

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AURORA: Longitudinal Assessment of Post-Traumatic Syndromes

The AURORA study is a major national research initiative to improve the understanding, prevention, and recovery of individuals who have experienced a traumatic event. AURORA is supported by more than 30 million dollars in funding from NIH, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily Life Sciences, the health care arm of Google’s parent company Alphabet. Five thousand participants who present to a consortium of the leading emergency departments in the nation will be enrolled. Trauma survivors participating in AURORA will receive initial evaluation in the emergency department, followed by intensive multimodal follow-up over a one year period. The wealth of first-in-kind information gained from this study will be used to develop predictive and diagnostic biomarkers and urgently needed preventive/treatment interventions for civilian trauma survivors and military veterans.

More information can be found at: UNC Institute for Trauma Recovery

QED: A Novel Serological Diagnostic Test for the Assessment of Traumatic Brain Injury

A patented blood test [will be used] to measure targets on small bits of material called extracellular vesicles, which are released from injured vessels during brain trauma. This research will utilize clinical samples to determine if there is a correlation between the level of the extracellular vesicles that are released from injured vessels and the severity of the traumatic brain injury. The technology has the long-term potential to support healthcare providers as they diagnose, monitor recovery and possibly predict outcomes associated with brain injuries.

More information can be found at: Temple University (LKSOM) Newsroom

BOOST-3: Brain Oxygen Optimization in Severe Traumatic Brain Injury-Phase 3

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.

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MOST: Multi-arm Optimization of Stroke Thrombolysis

The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset.

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AXIOMATIC: Factor XIa Inhibitor for Secondary Stroke Prevention

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

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CHEER: Capsule Endoscopy for Hemorrhage in the ER

This is a multi-center randomized controlled trial examining the use of Video Capsule Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal bleeds (UGIB) from the Emergency Department (ED.) The investigators will enroll 100 subjects at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk assessment to an Active Control (AC) group who receive inpatient upper endoscopy (EGD).

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CLOVERS: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.

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DIVERTICULITIS: Management of Diverticulitis in the Emergency Department

This study aims to describe current treatment practices in the US for managing acute uncomplicated diverticulitis. In addition, we will identify clinical factors associated with the decision to discharge versus hospitalize patients with uncomplicated diverticulitis with the goal of informing clinical decision-making and providing a foundation for diagnostic algorithms to guide clinical practice.

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