Ignite Creation Date:
2024-05-06 @ 2:07 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01973504
Status:
WITHDRAWN
Last Update Posted:
2013-10-31
First Post:
2013-08-20
Brief Title:
Phase 2c Dose Comparison Study of MP4OX in Trauma
Sponsor:
Sangart
Organization:
Sangart
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sangart ceased operations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None