Phase 2c Dose Comparison Study of MP4OX in Trauma

• Status: Withdrawn
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.

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

Details

• Lead Sponsor: Sangart

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Massive injury incompatible with life

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

• Evidence of severe traumatic brain injury (TBI) as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Known AIS (head region) ≥ 4 by an appropriate imaging methodology; Contemplated CNS surgery; Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level; or Glasgow Coma Score (GCS) = 3, 4 or 5.

• Cardiac arrest prior to randomization

• Known 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