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.
2.) To determine whether the rejuvenation of stored allogeneic red blood cells prior to transfusion will reduce postoperative organ injury in cardiac surgery patients at risk of large volume blood transfusion.
3.) To establish whether the observed effects of red cell rejuvenation are attributable to changes in endothelial, platelet and/or monocyte activation, or improved tissue oxygenation.

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.