Status:
COMPLETED
Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients
Lead Sponsor:
Sangart
Conditions:
Shock, Hemorrhagic
Shock, Traumatic
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 hemoglobi...
Detailed Description
Acute traumatic injury, including both blunt and penetrating injury, is often associated with severe uncontrolled bleeding which can lead to hemorrhagic shock. During shock, inadequate blood flow resu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT01262196
Start Date
May 1 2011
End Date
November 1 2012
Last Update
August 22 2013
Active Locations (40)
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1
Liverpoool Hospital NSW
Liverpool, Australia
2
John Hunter Hospital
Newcastle, Australia
3
Graz University Hospital
Gratz, Austria
4
Faculdade de Medicina de S. J. Do Rio Preto
São José do Rio Preto, Brazil