Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01004198
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2009-10-28
Brief Title:
Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients
Sponsor:
Sangart
Organization:
Sangart
Study Overview
Official Title:
A Multi-center Randomized Double-blind Controlled Dose-finding Study to Evaluate the Safety and Efficacy of MP4OX Treatment Plus Standard of Care in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Acute traumatic injury including both blunt and penetrating injury is often associated with severe bleeding which can lead to hemorrhagic shock During shock inadequate perfusion of critical organs can lead to local ischemia and tissue hypoxia insufficient oxygenation which can be detected by an increase in serum lactate levels Despite optimal care more than 10 of trauma victims who reach hospital alive will die and many will suffer from organ failure Death and significant persistent morbidity are consequences of trauma and traumatic injuries are associated with lost productivity reduced quality of life and direct costs to patients and health care systems worldwide Current therapies which also include blood transfusion are aimed at supporting failing organs but a therapeutic agent that could help to quickly restore adequate oxygenation may be beneficial to prevent or shorten duration of organ failure and improve patient outcome
Direct support for the proposed clinical application to use MP4OX in resuscitation from hemorrhage is found in preclinical animal studies Using a pig model of uncontrolled hemorrhage and resuscitation survival was greater and restoration of hemodynamics and acid-base status were improved with MP4OX relative to an equivalent volume of crystalloid pentastarch or unmodified hemoglobin Administration of MP4OX improved 24-hour survival stabilized cardiac output and arterial pressure at nearly normal levels and reduced lactate levels more effectively than the control fluids Importantly these benefits of MP4OX were observed with or without co-administration of autologous blood suggesting that blood alone was not sufficient to achieve complete resuscitation and that the effects of MP4OX appear to be additional to those of blood
Direct support for the proposed clinical application to use MP4OX in resuscitation from hemorrhage is found in preclinical animal studies Using a pig model of uncontrolled hemorrhage and resuscitation survival was greater and restoration of hemodynamics and acid-base status were improved with MP4OX relative to an equivalent volume of crystalloid pentastarch or unmodified hemoglobin Administration of MP4OX improved 24-hour survival stabilized cardiac output and arterial pressure at nearly normal levels and reduced lactate levels more effectively than the control fluids Importantly these benefits of MP4OX were observed with or without co-administration of autologous blood suggesting that blood alone was not sufficient to achieve complete resuscitation and that the effects of MP4OX appear to be additional to those of blood
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