Clinical Trial: Phase 2c Dose Comparison Study of MP4OX in Trauma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Multi-center, Multinational, Randomized, Double-blind, Controlled, Dose Comparison Study to Evaluate Safety and Efficacy of MP4OX Plus Standard Treatment, in Severely Injured Trauma Subjects With

Brief 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.

Detailed Summary:

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.


Sponsor: Sangart

Current Primary Outcome: Proportion of subjects discharged from hospital through Day 28 and alive at the Day 28 Follow up visit [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hospital-free, ICU-free, and Ventilator-free days [ Time Frame: Through 28 and 60 days ]
  • Proportion of subjects remaining in hospital, ICU or on ventilator [ Time Frame: Through 28 and 60 days ]
  • Days in hospital, in ICU, or on Ventilator [ Time Frame: Through 28 and 60 days ]
  • All-cause Mortality [ Time Frame: At 48 hours and 28 or 60 days ]
  • Time to discharge from ICU, hospital discharge, or liberation from ventilation [ Time Frame: Through 28 or 60 days ]
  • Composite of Time to Complete Organ Failure Resolution (CTCOFR) [ Time Frame: Day 21 ]


Original Secondary Outcome: Same as current

Information By: Sangart

Dates:
Date Received: August 20, 2013
Date Started: December 2013
Date Completion: March 2016
Last Updated: October 25, 2013
Last Verified: October 2013