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Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients

NCT01262196 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2013-08-22

No results posted yet for this study

Summary

MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

Conditions

  • Shock, Hemorrhagic
  • Shock, Traumatic
  • Acidosis, Lactic

Interventions

DRUG

MP4OX

4.3 g/dL pegylated hemoglobin in balanced lactate-electrolyte solution

DRUG

Saline

Normal saline (0.9%) solution

Sponsors & Collaborators

  • Sangart

    lead INDUSTRY

Principal Investigators

  • Karim Brohi, MD · The Royal London Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • Australia
  • Austria
  • Brazil
  • Colombia
  • France
  • Germany
  • Israel
  • New Zealand
  • Norway
  • Singapore
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262196 on ClinicalTrials.gov