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Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients

NCT01004198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2013-08-19

No results posted yet for this study

Summary

MP4OX is a novel oxygen therapeutic agent specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. MP4OX is a pegylated hemoglobin-based colloid and and as a result of its molecular size and unique oxygen dissociation characteristics, targets oxygen delivery to ischemic tissues by selectively off-loading oxygen in tissues predisposed to low oxygen tension. Sangart is currently evaluating MP4OX to reduce organ dysfunction and failure in trauma patients with lactic acidosis due to severe hemorrhagic shock.

Conditions

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

Interventions

DRUG

MP4OX

4.3 g/dL PEG-Hb solution in lactated electrolyte solution

DRUG

MP4OX

4.3 g/dL PEG-Hb solution in lactated electrolyte solution

DRUG

Ringers Lactate solution

Ringers Lactate solution for Injection

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

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • France
  • Germany
  • South Africa
  • 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 NCT01004198 on ClinicalTrials.gov