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

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.

Association Among Blood Transfusion, Postoperative Infectious Complications, and Cancer-Specific Survival in Patients with Stage II/III Gastric Cancer After Radical Gastrectomy: Emphasizing Benefit from Adjuvant Chemotherapy

“…In fact, some prospective, multicenter, large-scale studies have compared short and long outcomes after restrictive (hemoglobin \ 70 or 75 g/L) or liberal (hemoglobin \ 90 or 85 g/L) levels during surgery or after hematopoietic cell transplantation and concluded that a restrictive transfusion strategy would reduce the number of transfusions required without impacting on the mortality rate. 30,31 It seems inappropriate to copy their experiences verbatim in patients who underwent gastrectomy and, more importantly, whether different BTF strategies would influence the prognosis of patients with malignancy, but this issue has rarely been investigated. Preoperative iron supplementation and transfusion with leukocyte-depleted red blood cells also may be useful strategies to reduce the requirement for transfusion and the rate of occurrence of infections.…”

International Forum on Transfusion Practices in Haematopoietic Stem‐Cell Transplantation: Responses

“…The typical threshold for red cell transfusion in a stable post‐transplant patient is Hb < 80 g/l. We note the recent publication by Tay and colleagues reporting similar quality of life and other outcomes in HSCT patients using restrictive (Hb 70 g/l) compared with liberal (Hb 90 g/l) thresholds for RBC transfusion [2].…”

Real-World Issues and Potential Solutions in Hematopoietic Cell Transplantation during the COVID-19 Pandemic: Perspectives from the Worldwide Network for Blood and Marrow Transplantation and Center for International Blood and Marrow Transplant Research Health Services and International Studies Committee

“…The transfusion thresholds should be minimized in the light of an actual or anticipated shortage of blood products. As a general guideline, a hemoglobin threshold of <70 g/L should be considered as an indication for blood transfusion in both autologous and allogeneic HCT recipients [30] . For platelet transfusion, a threshold of <10 × 10 9 /μL is reasonable in most cases.…”