Trauma with lactic acidosis due to hemorrhagic shock MedDRA version: 12.0 Level: LLT Classification code 10023676 Term: Lactic acidosis
Conditions
Interventions
Product Name: MP4OX
Product Code: MP4OX
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Polyethylene Glycol Human Hemoglobin Conjugate
Current Sponsor code: PEG-Hb
Concentration unit: g
Sponsors
Sangart, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety and efficacy of MP4OX treatment compared to Ringer’s Lactate solution, in addition to standard of care, in severely injured trauma patients with lactic acidosis due to hemorrhagic shock.;Secondary Objective: The following secondary efficacy variables will be measured for each patient during the study: • All-cause 28 day mortality • Time (days) from randomization to death • Ventilator-free days (over 28 days) • Time (days) from randomization to ventilator-free days • ICU-free days (over 28 days) • Time (days) from randomization to ICU free days • Daily SOFA score • Daily modified Denver score • CTCOFR21 (evaluated at 21 days) • CTCOFR14 (evaluated at 14 days) • Hospital-free days (over 28 days) • Time (days) from randomization to hospital free days;Primary end point(s): The primary efficacy endpoint is the 2-hour lactate clearance. Lactate clearance will be calculated as follows: (Lactate 0-hour– Lactate 2-hour) / (Lactate 0-hour) X 100 Patients who do not complete the infusion of investigational product nor have both hour zero and 2-hour lactate samples collected will be replaced. The period of maximum lactate clearance (%) will also be calculated. The minimum effective dose for MP4 group will be chosen to maximize the decrease in lactate levels within the first 8 hours after completion of investigational product infusion. | — |
Countries
France, Germany, United Kingdom
Outcome results
None listed