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

• Conditions: Trauma with lactic acidosis due to hemorrhagic shock; MedDRA version: 12.0Level: LLTClassification code 10023676Term: Lactic acidosis

• Registration Number: EUCTR2009-013115-35-GB
• Lead Sponsor: Sangart, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

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. Adult male or female (surgically sterile or post-menopausal or not pregnant), aged 18 to 80 years or of legal age to consent for participation in an investigational drug trial as per local law.

3. Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock.
a. Lactic acidosis (lactate = 5 mmol/L; equivalent to = 45 mg/dL)
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. Not expected to survive 24 hours after randomization (based on physician judgment)
a. Massive injury incompatible with life

2. 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; Glasgow Coma Score (GCS) = 3, 4 or 5, or known AIS = 5 if GSC > 5
b. Immediate open intracranial operation
c. Abnormal physical exam indicative of severe CNS or spinal injury

3. Patients with significant ongoing uncontrolled hemorrhage where control of bleeding is not expected within 2 hours of randomization.

4. Cardiac arrest prior to dosing.

5. Estimated time from injury to dosing > 4 hours.

6. Estimated time from hospital admission to randomization > 2 hours.

7. Known or suspected pregnancy (confirmed by urine test).

8. Previous participation in this study.

9. Professional or ancillary personnel involved with this study.

10. 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