Clinical Trial: Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of MP4OX Treatment, in Addition to Standard Treatment, in Severely Injured Trauma Patients With Lactic Ac

Brief Summary: MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

Detailed Summary:

Acute traumatic injury, including both blunt and penetrating injury, is often associated with severe uncontrolled bleeding which can lead to hemorrhagic shock. During shock, inadequate blood flow results in local ischemia and tissue hypoxia (insufficient oxygenation) of critical organs, which can be detected by an increase in serum lactate levels in these trauma victims. 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.

The primary treatment of trauma is to support ventilation and oxygenation, limit blood loss, and maintain cardiovascular function so that organs are perfused. The patient's airway may be intubated to allow oxygenated airflow to the lungs. Mechanical ventilation is used if the patient cannot maintain oxygenation and carbon dioxide elimination. Damage-control surgery is used to limit blood loss and to intentionally delay definitive repair until the patient can better tolerate procedures. Blood transfusions are provided to maintain the oxygen-carrying capacity of the circulation. Platelets and coagulation factors are infused to correct any coagulopathy from dilution of blood and consumption of clotting factors. Vasopressor and inotropic agents may be used to support low cardiac output or blood pressure. Renal replacement therapy may be instituted if kidney failure occurs.

Despite optimal care, organ dysfunction is present in many patients. Hypoperfusion and anaerobic metabolism of organs and tissues can be detected by the presence of lactic acidosis. Current therapy is aimed at supporting failing organs, but an a
Sponsor: Sangart

Current Primary Outcome: Proportion of patients 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 days ]
  • Composite endpoint of Time to Complete Organ Failure Resolution (CTCOFR) [ Time Frame: At 14 and 21 days ]
  • Proportion of patients who normalize (≤ 2.2 mmol/L) lactate levels [ Time Frame: 2, 4, 6, 8 and 12 hours ]
  • Proportion of patients remaining: (1) in hospital, (2) in ICU, and (3) on ventilator through Day 28 [ Time Frame: 28 days ]
  • Number of days: (1) in hospital, (2) in ICU, and (3) on the ventilator [ Time Frame: Through 28 days ]
  • All-cause mortality [ Time Frame: At 48 hours and at 28 days ]
  • Time (days) from randomization to: (1) death, (2) discharge from hospital, (3) discharge from ICU, and (4) liberation from mechanical ventilation [ Time Frame: Through 28 days ]
  • Sequential organ failure assessment (SOFA score) [ Time Frame: Daily ]
  • Modified Denver score [ Time Frame: Daily ]


Original Secondary Outcome: Same as current

Information By: Sangart

Dates:
Date Received: December 15, 2010
Date Started: May 2011
Date Completion:
Last Updated: August 20, 2013
Last Verified: August 2013