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Liberal Versus Restrictive Red Blood Cell Transfusion Thresholds in Hematopoietic Cell Transplantation: A Randomized, Open Label, Phase III, Noninferiority Trial

University of Calgary Tom Baker Cancer Center, Calgary, Alberta, Canada. Ottawa Hospital Centre for Transfusion Research, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. Department of Medicine, Ottawa Hospital, Ottawa, Ontario, Canada. School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada. Saskatoon Cancer Center, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. Department of Medicine, London Health Sciences Centre, London, Ontario, Canada. Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, Ontario, Canada.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2020;:Jco1901836
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PICO Summary

Population

Patients with haematologic malignancies requiring haematopoietic cell transplantation (HCT) across four Canadian HCT centres, (n=300).

Intervention

Restrictive red blood cell transfusion (RBC) strategy (haemoglobin [Hb] threshold < 70 g/L), (n= 150).

Comparison

Liberal RBC transfusion strategy (Hb threshold < 90 g/L), (n= 150).

Outcome

After HCT, mean pre-transfusion Hb levels were 70.9 g/L in the restrictive-strategy group and 84.6 g/L in the liberal-strategy group. The number of RBC units transfused was lower in the restrictive-strategy group than in the liberal-strategy group (mean, 2.73 units vs. 5.02 units). After adjusting for transfusion type and baseline Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) score, the restrictive-strategy group had a higher FACT-BMT score at day 100 (difference of 1.6 points), which was non-inferior compared with that of the liberal-strategy group. There were no significant differences in clinical outcomes between the transfusion strategies.
Abstract
PURPOSE Evidence regarding red blood cell (RBC) transfusion practices and their impact on hematopoietic cell transplantation (HCT) outcomes are poorly understood. PATIENTS AND METHODS We performed a noninferiority randomized controlled trial in four different centers that evaluated patients with hematologic malignancies requiring HCT who were randomly assigned to either a restrictive (hemoglobin [Hb] threshold < 70 g/L) or liberal (Hb threshold < 90 g/L) RBC transfusion strategy between day 0 and day 100. The noninferiority margin corresponds to a 12% absolute difference between groups in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) score relative to baseline. The primary outcome was health-related quality of life (HRQOL) measured by FACT-BMT score at day 100. Additional end points were collected: HRQOL by FACT-BMT score at baseline and at days 7, 14, 28, 60, and 100; transplantation-related mortality; length of hospital stay; intensive care unit admissions; acute graft-versus-host disease; Bearman toxicity score; sinusoidal obstruction syndrome; serious infections; WHO Bleeding Scale; transfusion requirements; and reactions to therapy. RESULTS A total of 300 patients were randomly assigned to either restrictive-strategy or liberal-strategy treatment groups between 2011 and 2016 at four Canadian adult HCT centers. After HCT, mean pre-transfusion Hb levels were 70.9 g/L in the restrictive-strategy group and 84.6 g/L in the liberal-strategy group (P < .0001). The number of RBC units transfused was lower in the restrictive-strategy group than in the liberal-strategy group (mean, 2.73 units [standard deviation, 4.81 units] v 5.02 units [standard deviation, 6.13 units]; P = .0004). After adjusting for transfusion type and baseline FACT-BMT score, the restrictive-strategy group had a higher FACT-BMT score at day 100 (difference of 1.6 points; 95% CI, -2.5 to 5.6 points), which was noninferior compared with that of the liberal-strategy group. There were no significant differences in clinical outcomes between the transfusion strategies. CONCLUSION In patients undergoing HCT, the use of a restrictive RBC transfusion strategy threshold of 70 g/L was as effective as a threshold of 90 g/L and resulted in similar HRQOL and HCT outcomes with fewer transfusions.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine