Clinical Trials

Study TRA-204 – Phase IIa Trauma study (Europe & S. Africa)

Details
This is a phase IIa dose-finding study to evaluate the safety and efficacy study of MP4OX plus standard of care in trauma patients with lactic acidosis due to hemorrhagic shock. Patients eligible for randomization must be in hemorrhagic shock, with evidence of lactic acidosis (serum lactate level ≥ 5 mmol/L; equivalent to ≥ 45 mg/dL) within 2 hours after arrival at study hospital and within 4 hours of traumatic injury. Initial dose of either 250-mL of MP4OX plus 250-mL of Ringer's Lactate, or 500-mL dose of MP4OX, or 500-mL of Ringer's Lactate, will be initiated within 30 minutes of randomization.

The primary objective in this study is to evaluate the safety and efficacy of MP4OX treatment at 2 dose levels (250 and 500 mL) compared to isotonic Ringer's lactate solution, in addition to standard of care, in severely injured trauma patients exhibiting lactic acidosis within the first 2 hours after arrival at the hospital and within 4 hours of trauma. The secondary objectives of this study will be to evaluate early and late mortality, time to transfer from ICU and discharge from hospital and the duration of organ failure as measured by serial SOFA and modified Denver Score and days on mechanical ventilation, renal replacement therapy or vasopressors, and a morbidity outcome composite endpoint of time to complete organ failure resolution (CTCOFR), defined as the last day on which the patient no longer needs any vasoactive agents, mechanical ventilation, or renal replacement support through study Day 14 or Day 21. Serious adverse events and mortality outcome will be evaluated through Day 28. [Additional details about this protocol can be found at http://clinicaltrials.gov/ct/show/NCT01004198?order=3]