This study will assess the safety and effectiveness of MP4OX when added to standard treatment for trauma patients who are severely insured and bleeding.
- Conditions
- severely injured trauma patients with lactic acidosis due to hemorrhagic shockMedDRA version: 14.1Level: LLTClassification code 10050841Term: Hemorrhagic shockSystem Organ Class: 100000004866MedDRA version: 14.1Level: PTClassification code 10023676Term: Lactic acidosisSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2010-023129-39-DE
- Lead Sponsor
- Sangart, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
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 (NOTE: insertion of an intra-cranial pressure device is not considered CNS surgery)
e)Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level
NOTE: Patients with a GCS of less than 6 at the time of enrollment may be enrolled, but it is expected that if they are enrolled, they will clearly meet all of the following conditions:
- Documented GCS of 6 or greater at the scene
- No physical evidence of head injury at the scene
- No evidence of brain injury by appropriate imaging techniques at the hospital
- The patient is intubated and sedated and the depressed GCS can be reasonably be attributed to the sedation given to perform or maintain intubation
- No other exclusionary neurological conditions (such as high spinal cord injury etc)
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.;Timepoint(s) of evaluation of this end point: day 28
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -