Evaluation of MP4OX treatment in severely injured trauma patients
Research type
Research Study
Full title
A multi-centre, randomised, 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 acidosis due to haemorrhagic shock.
IRAS ID
71157
Contact name
Karim Brohi
Sponsor organisation
Sangart, Inc.
Eudract number
2010-023129-39
Clinicaltrials.gov Identifier
Research summary
Trauma is often associated with severe uncontrolled bleeding which can lead to haemorrhagic shock (Shock caused by bleeding). During haemorrhagic shock, the loss of blood leads to insufficient oxygen reaching the body??s tissues. This causes them to become oxygen deprived which damages the organs and can lead to organ failure and other complications. Cells that lack oxygen produce lactic acid (lactate). The level of lactate in the blood can be measured and is a marker of the severity of haemorrhagic shock and this lack of cellular oxygen. Despite optimal care, more than 10% of trauma victims who reach hospital alive will die, and many more will suffer from organ failure, infection and other complications. Death and severe disability are consequences of trauma, and injuries are associated with lost productivity, reduced quality of life, and direct costs to patients and health care systems worldwide. The main treatment of haemorrhagic shock in trauma is to support oxygen being delivered to organs, stop bleeding and replace lost blood with blood transfusions and clotting factors. Despite the best care, it often takes several hours to restore oxygen delivery to the cells to normal. Lactate levels can remain high for many hours indicating that cells are still not receiving enough oxygen and that organ damage is occurring. This deficiency in oxygen delivery can occur even when enough blood transfusions have been given to restore a patient??s original blood volume to normal. Studies in critically ill intensive care patients have demonstrated that elevated initial and 24-hour lactate levels are significantly associated with death, and prolonged elevation of blood lactate levels after trauma has been correlated with increased organ failure and infections. The study drug, MP4OX aims to reduce the damage caused to tissues and organs by haemorrhagic shock in trauma. MP4OX is a drug that is a modified form of human haemoglobin (the molecule in blood that carries oxygen). MP4OX carries oxygen and increases the amount of oxygen delivered to the tissues. The effectiveness of MP4OX in supplying oxygen to oxygen deprived organs and treating haemorrhagic shock has been shown in experiments on animals and early research studies in trauma patients. The purpose of this research study is to find out if the study drug, MP4OX, given together with standard treatment, is safe and effective in treating severely injured trauma patients with haemorrhagic shock. Emergency consent procedures will follow those described in the Mental Capacity Act 2005. Potential Participants will be screened for their eligibility to take part in this study within 2 hours of being admitted to hospital for a severe trauma injury. Eligible participants will then be randomly assigned (assigned by chance like the flipping of a coin) to treatment with wither MP4OX or saline solution (a placebo; a visibly identical treatment containing no active ingredient). Neither participants nor their study doctor will know which treatment they have been assigned to (double-blinded study design). Participants will be followed for 28 days. Approximately 360 severely injured trauma patients will take part in this study, across approximately 75 research sites worldwide. The study will be sponsored by Sangart Inc.
REC name
Wales REC 3
REC reference
11/WA/0006
Date of REC Opinion
21 Mar 2011
REC opinion
Further Information Favourable Opinion