Clinical Trials

Study TRA-205 – Phase 2b Trauma study (Worldwide, non-US)

Details
This is a multicenter, international, double-blind, phase 2 study being conducted worldwide (non-US) to evaluate the safety and efficacy of MP4OX plus standard of care in 360 trauma patients with lactic acidosis due to severe hemorrhagic shock. Trauma patients eligible for enrollment must have confirmed evidence of lactic acidosis (serum lactate level ≥ 5 mmol/L; equivalent to ≥ 45 mg/dL) due to severe hemorrhagic shock, and will be randomized within 2 hours after arrival at study hospital and within 4 hours of traumatic injury. MP4OX is administered at an initial dose of 250 mL (controls receive 250-mL of normal saline), with replacement doses as needed within the first 12 hours, to compensate for ongoing uncontrolled hemorrhage following transfusion of each additional 4 units of red blood cells plus intravenous fluids.

The primary goal of this study is to demonstrate that a greater proportion of MP4OXtreated patients are discharged from the hospital through day 28 and are alive at 28-day follow up as compared to controls. This study is also intended to demonstrate more rapid reversal of lactic acidosis and durable normalization of serum lactate levels following MP4OX treatment, and thereby potentially decrease the degree and duration of hemorrhagic shock-induced organ dysfunction and organ failure. Lactate is being used as a relevant biomarker for indicating potential improvement in organ dysfunction or failure, since an elevated serum lactate level indicates the presence of insufficient perfusion of tissues and anaerobic metabolism, and represents the level of oxygen debt and the severity of hemorrhage shock.

Other secondary objectives of this study include: early and late mortality; time to transfer out of ICU; time to discharge from hospital; duration of organ failure as measured by serial SOFA and modified Denver Score; 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. [Protocol details can be found at http://clinicaltrials.gov/ct/show/NCT01262196]