Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. MP4OX is a pegylated hemoglobin-based colloid and and as a result of its molecular size and unique oxygen dissociation characteristics, targets oxygen delivery to ischemic tissues by selectively off-loading oxygen in tissues predisposed to low oxygen tension. Sangart is currently evaluating MP4OX to reduce organ dysfunction and failure in trauma patients with lactic acidosis due to severe hemorrhagic shock.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sangart
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Adult male or female (surgically sterile or post-menopausal or confirmed not to be pregnant)

• Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock (blood lactate level ≥ 5 mmol/L; equivalent to ≥ 45 mg/dL)

• Informed consent obtained before any study-related activities

Exclusion Criteria:

• Not expected to survive 24 hours after randomization

• Evidence of severe traumatic brain injury as defined by any one of the following:

Known non-survivable head injury or open brain injury; Glasgow Coma Score (GCS) = 3, 4 or 5, or known AIS = 5 if GCS > 5; Immediate open intracranial operation; Abnormal physical exam indicative of severe CNS or spinal injury

• Significant ongoing uncontrolled hemorrhage where control of bleeding is not expected within 2 hours of randomization

• Cardiac arrest prior to dosing

• Estimated time from injury to dosing > 4 hours

• Estimated time from hospital admission to randomization > 2 hours

• Known or suspected pregnancy (confirmed by urine test)

• Previous participation in this study

• Professional or ancillary personnel involved with this study

• Receipt of any investigational drug(s) within 30 days prior to study