Evaluation of the efficacy and safety of amustaline/glutathione pathogen-reduced RBCs in complex cardiac surgery: the Red Cell Pathogen Inactivation (ReCePI) study-protocol for a phase 3, randomized, controlled trial.
Edward L SnyderMichael E SekelaIan J WelsbyYoshiya ToyodaMohamed AlsammakNeel R SodhaThomas M BeaverJ Peter R PelletierJames D GorhamJohn S McNeilRoman M SniecinskiRonald G PearlGregory A NuttallRavi SarodeT Brett ReeceAlesia KaplanRobertson D DavenportTina S IpePeyman BenharashIleana Lopez-PlazaRichard R GammonPatrick SadlerJohn P PitmanKathy LiuStanley BentowLaurence CorashNina MuftiJeanne VarroneRichard J Benjaminnull nullPublished in: Trials (2023)
RBCs are transfused to prevent tissue hypoxia caused by surgery-induced bleeding and anemia. AKI is a sensitive indicator of renal hypoxia and a novel endpoint for assessing RBC efficacy. The ReCePI study is intended to demonstrate the non-inferiority of pathogen-reduced RBCs to conventional RBCs in the support of renal tissue oxygenation due to acute anemia and to characterize the incidence of treatment-related antibodies to RBCs.
Keyphrases
- randomized controlled trial
- cardiac surgery
- acute kidney injury
- candida albicans
- chronic kidney disease
- drug induced
- minimally invasive
- endothelial cells
- liver failure
- iron deficiency
- study protocol
- single cell
- atrial fibrillation
- risk factors
- coronary artery bypass
- intensive care unit
- cell therapy
- systematic review
- respiratory failure
- hepatitis b virus
- stem cells
- bone marrow
- surgical site infection