REDJUVENATE
Research type
Research Study
Full title
A RANDOMISED CONTROLLED TRIAL OF RED CELL REJUVENATION FOR THE ATTENUATION OF TRANSFUSION ASSOCIATED ORGAN INJURY IN CARDIAC SURGERY: The REDJUVENATE Trial
IRAS ID
224081
Contact name
Gavin J. Murphy
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
The aim of the study is to establish whether patients at increased risk of a blood transfusion can be transfused with rejuvenated red blood cells, and whether this will reduce organ injury after the operation.
Severe complications from infections or organ injury affecting the kidney, heart and lungs are the main contributors to death and high healthcare costs following heart surgery. These complications are common and once established, treatment is essentially supportive. Transfusion of older red blood cells is thought to increase these risks, however red blood cell transfusion is very common in heart surgery patients, and so defining the appropriate and safe use of donor blood is a priority.
An alternative strategy in patients who must receive blood transfusions is to make stored red blood cells safer. We have shown that rejuvenating red blood cells can prevent organ injury in the laboratory. We now want to see if the transfusion of rejuvenated red blood cells can reduce complications from infections or organ injury in heart surgery patients.
In the REDJUVENATE trial, we want to compare the levels of organ injury and immune system response in heart surgery patients at risk of a large volume blood transfusion (defined as the administration of ≥4 units of red cells) receiving rejuvenated red blood cells compared to patients receiving standard care (non-rejuvenated, stored red blood cells).
This is a triple blinded clinical trial whereby the patient, the clinical staff and most of the research staff will not be aware of the patient's treatment. This is because we want to find out what the best treatment is without any bias that could influence the outcome of the trial. However, when we see the patient at their follow up visit we will ask them if they were aware of which treatment they had.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0327
Date of REC Opinion
20 Nov 2017
REC opinion
Further Information Favourable Opinion