REDJUVENATE
Title | REDJUVENATE: A randomised controlled trial of red cell rejuvenation for the attenuation of transfusion associated organ injury in cardiac surgery. |
Study Type | Randomised controlled trial |
Chief Investigator(s) | Professor Gavin Murphy |
Primary Sponsor | University of Leicester |
Research Theme | Organ Donation and Transplantation |
Summary |
The objectives of the study are the following: 1.) To establish whether patients at increased risk of red cell transfusion can be transfused with rejuvenated red cells. |
Study Design | This will be a single blinded, parallel group, randomised controlled trial. The trial design will include an initial feasibility phase of 20 patients to assess whether the intervention can be delivered on time, and to review recruitment rates, protocol compliance rates and withdrawal rates. |
Study Hypothesis |
Primary Hypothesis: Post-operative organ injury and inflammation will be reduced if patients undergoing cardiac surgery who are at risk of large volume blood transfusion (defined as the administration of ≥4 units of red cells) receive rejuvenated washed cells as compared to standard care (unwashed aged stored cells). Secondary Hypothesis: Rejuvenation will attenuate platelet and monocyte activation, oxidative stress, endothelial dysfunction and tissue hypoxia attributable to allogeneic red cell transfusion. |