Trauma Clinical Trial
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 Lactic Acidosis Due to Hemorrhagic Shock
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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