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Phase 2c Dose Comparison Study of MP4OX in Trauma

NCT01973504 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-10-31

No results posted yet for this study

Summary

MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.

Conditions

  • Trauma
  • Hemorrhagic Shock
  • Lactic Acidosis

Interventions

DRUG

MP4OX

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

DRUG

Control

Crystalloid solution IV infusion drip to keep vein open

Sponsors & Collaborators

  • Sangart

    lead INDUSTRY

Principal Investigators

  • Karim Brohi, MD · The Royal London Hospital

  • Frank V. Booth, BCh, FACS · Sangart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Australia
  • Belgium
  • Brazil
  • France
  • Germany
  • Israel
  • New Zealand
  • Norway
  • South Africa
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01973504 on ClinicalTrials.gov