Red Cell Rejuvenation for the Attenuation of Transfusion Associated Organ Injury in Cardiac Surgery

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2020

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Organ Failure, MultipleInflammationSepsis
Interventions
DEVICE

rejuvesol Solution

The rejuvenation process involves incubation of stored red cells with a rejuvenating solution, rejuvesol Red Blood Cell Processing Solution (rejuvesol® Solution), Citra labs, MA, a Zimmer Biomet Company, IN, USA) which restores red cell adenosine triphosphate (ATP), 2,3-DPG (diphosphoglycerate), oxygen transfer characteristics and rheology. Post rejuvenation red cells are washed to remove the rejuvesol Solution, and cells are re-suspended in additive solution for transfusion.

OTHER

Standard Care

Allogeneic red cells, harvested in citrate-phosphate-dextrose (CPD), leucocyte depleted, saline-adenine-glucose-mannitol (SAGM) stored red cell units, issued by National Health Service Blood \& Transplant (NHSBT) will be administered to cardiac surgery patients as per standard practice, and according to established unit protocols.

Trial Locations (1)

LE3 9QP

Department of Cardiovascular Sciences, Leicester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Health Service, United Kingdom

OTHER_GOV

collaborator

Zimmer Biomet

INDUSTRY

collaborator

British Heart Foundation

OTHER

lead

University of Leicester

OTHER