Evaluation, safety, efficacy of MP4OX treatment in haemorrhagic shock

• Research type

  Research Study

• Full 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

• IRAS ID

  29744

• Contact name

  Karim Brohi

• Sponsor organisation

  Sangart, Inc.

• Eudract number

  2009-013115-35

• ISRCTN Number

  N/A

• Research summary

  Severe traumatic injury and blood loss can lead to poor oxygenation of tissues and production of lactic acid. If prolonged, this can cause disturbances of the body's physiological mechanisms and can lead to severe post-injury complications and organ failure. Lactic acid (Lactate) can be detected in a blood test. MP4OX has been shown to improve oxygen delivery to blood-starved tissues in animals and has been administered safely to normal healthy human volunteers and during elective surgical operations. This study aims to evaluate whether MP4OX treatment can safely improve oxygen delivery to tissues in trauma patients. We are the only UK centre and there are 13 other centres participating worldwide. We hope to recruit a total of 75 patients between the ages of 18 and 80 during the next 10 months. We estimate that approximately 20 will be from The Royal London Hospital. Trauma patients who have lactate levels above 5 mmol/L and have been admitted within 4 hours of their injury will be eligible for admission to the trial and randomisation. Patients will then receive one dose of either:* 250ml MP4OX plus 250ml Ringers Lactate Solution* 500ml MP4OX * 500ml Ringers Lactate Solution All other emergency treatments will be conducted, according to the needs of each patient, by clinical staff who are independent of the research team. Study personnel will be blinded to each participant's treatment group. Physical examination, documentation of vital signs, bedside tests and laboratory assessments will be carried out at specified intervals according to the trial protocol to evaluate efficacy of the treatment. Any safety issues will be reported to the review board according to regulations. Participants will be monitored from admission to day 28 or discharge, whichever is earliest.

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/96

• Date of REC Opinion

  5 Nov 2009

• REC opinion

  Further Information Favourable Opinion