Summary
Inflammatory Response In Major Injury & Recombinant Human Erythropoietin (IRMINE pilot study) ISCRTN Registration
Funder: Swansea Bay University Health Board (UK)
Background and study aims
Blunt trauma, also known as blunt force trauma, is a severe physical injury caused by impact of the head or body with a blunt object or surface. One of the most common injuries associated with blunt trauma is damage to the kidneys. The kidneys play a vital role in the body, producing a number of different hormones. One of these hormones, erythropoietin (EPO) stimulates the bone marrow to produce more red blood cells. Previous studies have shown that giving patients a manufactured version of this hormone, known as recombinant human erythropoietin (rhEPO) can help to protect patients with severe injuries from death. The reason why this happens is not known, however further studies have suggested that rhEPO may actually influence the immune system, reducing the risk of infection. The aim of this study is to find out whether treatment with rhEPO can help reduce organ failure rates and improve recovery in adults admitted to intensive care with injuries caused by blunt trauma.
Who can participate?
Adults admitted to intensive care unit (ITU) with blunt trauma with an injury severity score of at least 16.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first groups are given an injection under the skin (subcutaneous injection) of rhEPO 1, 8 and 15 days after they are admitted to the ITU. Participants in the second group are given a subcutaneous injection of a dummy (placebo) 1, 8 and 15 days after they are admitted to the ITU. Participants in both groups are monitored for 30 days after they are discharged from ITU in order to establish how many have multiple organ failure, how many survive and the time spent on the ITU ward.
What are the possible benefits and risks of participating?
Participants who receive rhEPO may benefit from a faster recovery as a result of the treatment. Risks of taking part are small however some patients may experience side-effects of rhEPO such as high blood pressure.
Where is the study run from?
Morriston Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2015 to December 2017
Contact Details
Trial Manager / Lead Contact: Dr Kym Carter
Phone: 01792 606372
Email: k.carter@swansea.ac.uk
Website: https://www.swansea.ac.uk/staff/medicine-health-life-science/medicine/health-data-science/carter-k/
ISCRTN Number: 40935649 ; Eudra CT Number: 2015-002255-10;