drugset / Trial / NCT04141631

Transfusion Savings in Heart Surgery: Impact of Individual Strategy by Erythropoietin and Metabolic Adjustment (ScvO2)

NCT04141631 ↗

Completed 128 enrolled University Hospital, Montpellier
RandomizedParallel-groupOpen-labelTreatment

Summary

Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be developed .The study evaluate an individual blood conservation strategy based on patient blood management bundles in cardiac surgery patients: optimisation perioperative hemoglobin level by erythropoietin and ferric carboxymaltose (Ferinject) associated with the use of ScV02 to guide perioperative erythrocyte transfusion.

Timeline

Start
2020-01-13
Primary completion
2022-05-10
Completion
2022-06-15

Outcome

Met primary endpoint

paper Nine patients (14.5%, 9/62) in the STOP group required RBC transfusion vs 19 (31.2%, 19/61) in the control group (odds ratio 0.37 [95% CI: 0.15-0.91], p = 0.03). PMID 39022429 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 20 mg/kg Intravenous
Subject epoetin alfa Protein / enzyme biologic 600 iu/kg Subcutaneous