Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

• 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

• Acidosis (blood lactate level ≥ 5 mmol/L; equivalent to 45 mg/dL) arterial or venous

Exclusion Criteria:

• Massive injury incompatible with life

• Normalization of lactate prior to dosing (≤ 2.2 mmol/L)

• Patients with 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; Known AIS (head region) ≥ 4 shown by an appropriate imaging methodology; Contemplated CNS surgery; or Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level

• Cardiac arrest prior to randomization

• Age below the legal age for consenting

• Estimated time from injury to randomization> 4 hours

• Estimated time from hospital admission to randomization > 2 hours

• Known pregnancy

• Use of any oxygen carrier other than RBCs

• Known previous participation in this study

• Professional or ancillary personnel involved with this study

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