A multi-center, randomized, double-blind, controlled study to evaluate the safety and efficacy of MP4OX treatment, in addition to standard treatment, in severely injured trauma patients with lactic acidosis due to hemorrhagic shock

• Conditions: severely injured trauma patients with lactic acidosis due to hemorrhagic shock; MedDRA version: 12.1Level: LLTClassification code 10050841Term: Hemorrhagic shock; MedDRA version: 12.1Level: LLTClassification code 10023676Term: Lactic acidosis

• Registration Number: EUCTR2010-023129-39-AT
• Lead Sponsor: Sangart, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-02
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1)Informed consent obtained before any study-related activities (study-related activities are any procedure that would not have been performed as standard of care for the patient)
2)Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock
3)Acidosis (blood lactate level = 5 mmol/L; equivalent to 45 mg/dL) arterial or venous
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Massive injury incompatible with life
2)Normalization of lactate prior to dosing (= 2.2mmol/L)
3)Patients with evidence of severe traumatic brain injury as defined by ANY one of the following:

a)Known non-survivable head injury or open brain injury
b)Glasgow Coma Score (GCS) = 3, 4 or 5
c)Known AIS (head region) = 4 shown by an appropriate imaging methodology
d)Contemplated CNS surgery
e)Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level

4)Cardiac arrest prior to randomization
5)Age below the legal age for consenting
6)Estimated time from injury to randomization> 4 hours
7)Estimated time from hospital admission to randomization > 2 hours
8)Known pregnancy
9)Use of any oxygen carrier other than RBCs
10)Known previous participation in this study
11)Professional or ancillary personnel involved with this study
12)Known receipt of any investigational drug(s) within 30 days prior to study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the safety and efficacy of 250 mL MP4OX treatment compared to 250 mL of normal saline solution plus replacement doses if continued hemorrhage, in addition to standard treatment, in severely injured trauma patients with lactic acidosis due to hemorrhagic shock.;Secondary Objective: -;Primary end point(s): The primary efficacy endpoint is the proportion of patients discharged from hospital through day 28 and alive at the Day 28 Follow up visit.