Recruitment

Recruitment Status
Withdrawn

Inclusion Criterias

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)
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)

Exclusion Criterias

Normalization of lactate prior to dosing (≤ 2.2 mmol/L)
Known pregnancy
Estimated time from injury to randomization > 4 hours
...
Normalization of lactate prior to dosing (≤ 2.2 mmol/L)
Known pregnancy
Estimated time from injury to randomization > 4 hours
Known receipt of any investigational drug(s) within 30 days prior to study
Cardiac arrest prior to randomization
Estimated time from hospital admission to randomization > 2 hours
Known age below the legal age for consenting
Known previous participation in this study
Use of any oxygen carrier other than RBCs
Professional or ancillary personnel involved with this study
Evidence of severe traumatic brain injury (TBI) as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Known AIS (head region) ≥ 4 by an appropriate imaging methodology; Contemplated CNS surgery; Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level; or Glasgow Coma Score (GCS) = 3, 4 or 5.
Massive injury incompatible with life

Summary

Conditions
  • Hemorrhagic Shock
  • Lactic Acidosis
  • Trauma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Acute trauma, including both blunt and penetrating injury, is often associated with uncontrolled bleeding that leads to hemorrhagic shock. During shock, inadequate blood flow results in local ischemia and tissue hypoxia (insufficient oxygenation) of critical organs with resulting lactic acidosis. Mo...

Acute trauma, including both blunt and penetrating injury, is often associated with uncontrolled bleeding that leads to hemorrhagic shock. During shock, inadequate blood flow results in local ischemia and tissue hypoxia (insufficient oxygenation) of critical organs with resulting lactic acidosis. More than 10% of trauma victims who reach hospital alive will die, and many will suffer from organ failure. The primary goal when treating traumatic hemorrhage is to control blood loss, support ventilation and oxygenation, and maintain cardiovascular function to maintain organ perfusion. Despite optimal care, organ dysfunction is present in many patients as evidenced by persistent lactic acidosis. Blood transfusions are intended to improve circulation of oxygen-carrying red blood cells, but are frequently insufficient, even when the hemoglobin level is optimized. The severity of lactic acidosis in trauma victims has also been shown to correlate with worse outcome. Support for the proposed application for MP4OX as a therapeutic adjunct to standard treatment of severe hemorrhage shock, is based on multiple preclinical studies in different animal models of hemorrhagic shock resuscitation. These preclinical studies demonstrated that survival was greater and restoration of acid-base status and hemodynamics were improved with MP4OX. The benefits of MP4OX in animals were observed with or without co-administration of autologous blood, demonstrating that red cell transfusion alone was insufficient, and that the effects of MP4OX were additive. The hypothesis for the current study is that MP4OX will enhance perfusion and oxygenation of ischemic organs and thereby prevent and reduce the duration of organ failure and improve morbidity and mortality outcome measures.

Inclusion Criterias

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)
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)

Exclusion Criterias

Normalization of lactate prior to dosing (≤ 2.2 mmol/L)
Known pregnancy
Estimated time from injury to randomization > 4 hours
...
Normalization of lactate prior to dosing (≤ 2.2 mmol/L)
Known pregnancy
Estimated time from injury to randomization > 4 hours
Known receipt of any investigational drug(s) within 30 days prior to study
Cardiac arrest prior to randomization
Estimated time from hospital admission to randomization > 2 hours
Known age below the legal age for consenting
Known previous participation in this study
Use of any oxygen carrier other than RBCs
Professional or ancillary personnel involved with this study
Evidence of severe traumatic brain injury (TBI) as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Known AIS (head region) ≥ 4 by an appropriate imaging methodology; Contemplated CNS surgery; Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level; or Glasgow Coma Score (GCS) = 3, 4 or 5.
Massive injury incompatible with life

Locations

Aachen
Liverpool
Clichy
Brussels
Ludwigshafen
...
Aachen
Liverpool
Clichy
Brussels
Ludwigshafen
Be'er-Sheva
Johannesburg
Lyon
Zurich
Jerusalem
São José do Rio Preto
Edegem
Cologne
Limoges
Cape Town
Soweto
Franfurt
São Paulo
Berlin
London
Le Kremlin Bicêtre Cedex
Newcastle
Oslo
Auckland
São Paulo
Haifa
Alberton
Paris Cedex
Johannesburg
Lausanne
Lille Cedex

Tracking Information

NCT #
NCT01973504
Collaborators
Not Provided
Investigators
  • Principal Investigator: Karim Brohi, MD The Royal London Hospital Study Chair: Frank V. Booth, BCh, FACS Sangart, Inc.
  • Karim Brohi, MD The Royal London Hospital Study Chair: Frank V. Booth, BCh, FACS Sangart, Inc.