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Health-related quality of life after restrictive versus liberal RBC transfusion for cardiac surgery: Sub-study from a randomized clinical trial

Department of Surgery, University of Melbourne, Parkville, Victoria, Australia. Department of Anaesthesia, Austin Health, Heidelberg, Victoria, Australia. Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Parkville, Victoria, Australia. Outcomes Research Consortium, The Cleveland Clinic, Cleveland, Ohio, USA. Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia. Statistical Consulting Centre, University of Melbourne, Parkville, Victoria, Australia. Melbourne Disability Institute, University of Melbourne, Parkville, Victoria, Australia. Centre for Health Analytics, Murdoch Children's Research Institute, Royal Children's Hospital, Parkville, Victoria, Australia. Department of Anaesthesia, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.

Transfusion. 2022
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PICO Summary

Population

Patients undergoing cardiac surgery, enrolled in the Australian cohort of the randomised controlled trial: Transfusion Requirements in Cardiac Surgery III (TRICS III), (n= 617).

Intervention

Restrictive transfusion strategy (n= 311).

Comparison

Liberal transfusion strategy (n= 306).

Outcome

Health-related quality of life (HRQOL) data were available for 208 (67%) patients in the restrictive and 217 (71%) patients in the liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery.
Abstract
BACKGROUND Transfusion Requirements in Cardiac Surgery III (TRICS III), a multi-center randomized controlled trial, demonstrated clinical non-inferiority for restrictive versus liberal RBC transfusion for patients undergoing cardiac surgery. However, it is uncertain if transfusion strategy affects long-term health-related quality of life (HRQOL). STUDY DESIGN AND METHODS In this planned sub-study of Australian patients in TRICS III, we sought to determine the non-inferiority of restrictive versus liberal transfusion strategy on long-term HRQOL and to describe clinical outcomes 24 months postoperatively. The restrictive strategy involved transfusing RBCs when hemoglobin was <7.5 g/dl; the transfusion triggers in the liberal group were: <9.5 g/L intraoperatively, <9.5 g/L in intensive care, or <8.5 g/dl on the ward. HRQOL assessments were performed using the 36-item short form survey version 2 (SF-36v2). Primary outcome was non-inferiority of summary measures of SF-36v2 at 12 months, (non-inferiority margin: -0.25 effect size; restrictive minus liberal scores). Secondary outcomes included non-inferiority of HRQOL at 18 and 24 months. RESULTS Six hundred seventeen Australian patients received allocated randomization; HRQOL data were available for 208/311 in restrictive and 217/306 in liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery. DISCUSSION The non-inferiority of a restrictive compared to a liberal transfusion strategy was not established for long-term HRQOL in this dataset.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine