IRMINE pilot
Research type
Research Study
Full title
INFLAMMATORY RESPONSE IN MAJOR INJURY & RECOMBINANT HUMAN ERYTHROPOIETIN (IRMINE) - A PILOT STUDY
IRAS ID
183364
Contact name
Ian Pallister
Contact email
Sponsor organisation
Abertawe Bro Morgannwg University Health Board
Eudract number
2015-002255-10
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This pilot study will help us develop a large scale study to see whether a drug called rhEPO helps adults recover after major injuries. rhEPO is a copy of a natural hormone, commonly used to treat anaemia in long term conditions. A previous study in ITU major trauma patients unexpectedly suggested fewer died if they had received rhEPO. This may be because of effects on the immune system, the bone marrow which produces white blood cells to fight infection, or changes in the way cells in the body resist damage or generate power in order to keep working properly. This is a randomised controlled trial, half of the patients receive rhEPO, and the other half placebo. No one looking after the patients knows whether they have had rhEPO or not. This avoids medical staff inadvertently doing things differently when they know the trial drug has been given. Because of the severity of injuries, it is not possible to obtain consent from patients before entering them into the study. On day 1 after admission, after checking that there are no medical reasons to exclude them, patients are randomised to receive an injection (rhEPO/placebo), which is repeated every 7 days, while they are on ITU. Each day blood is taken for research, and careful note made of clinical progress. On day 2 after admission, a sample of blood will be collected from their bone marrow (from the hip). No further samples will be taken once the patient has left ITU, but note will be made of their survival to 30 days after injury. Once they are recovering, we give them all the information relating to the study, answer any questions that they may have about how and why the study was performed, and ask them to confirm their consent to be involved.
REC name
Wales REC 3
REC reference
15/WA/0361
Date of REC Opinion
26 Jan 2016
REC opinion
Further Information Favourable Opinion