Jason Tay1,2, David S Allan2,3, Elizabeth Chatelain2, Doug Coyle4, Mohamed Elemary5, Adrienne Fulford6, William Petrcich2, Timothy Ramsay2,4, Irwin Walker7, Anargyros Xenocostas6, Alan Tinmouth2,3, Dean Fergusson2,4. 1. University of Calgary Tom Baker Cancer Center, Calgary, Alberta, Canada. 2. Ottawa Hospital Centre for Transfusion Research, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 3. Department of Medicine, Ottawa Hospital, Ottawa, Ontario, Canada. 4. School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada. 5. Saskatoon Cancer Center, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. 6. Department of Medicine, London Health Sciences Centre, London, Ontario, Canada. 7. Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, Ontario, Canada.
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 treatmentgroups 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.
RCT Entities:
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.
Authors: Jeffrey L Carson; Simon J Stanworth; Jane A Dennis; Marialena Trivella; Nareg Roubinian; Dean A Fergusson; Darrell Triulzi; Carolyn Dorée; Paul C Hébert Journal: Cochrane Database Syst Rev Date: 2021-12-21
Authors: Ghada Algwaiz; Mahmoud Aljurf; Mickey Koh; Mary M Horowitz; Per Ljungman; Daniel Weisdorf; Wael Saber; Yoshihisa Kodera; Jeff Szer; Dunia Jawdat; William A Wood; Ruta Brazauskas; Leslie Lehmann; Marcelo C Pasquini; Adriana Seber; Pei Hua Lu; Yoshiko Atsuta; Marcie Riches; Miguel-Angel Perales; Nina Worel; Shinichiro Okamoto; Alok Srivastava; Roy F Chemaly; Catherine Cordonnier; Christopher E Dandoy; John R Wingard; Mohamed A Kharfan-Dabaja; Mehdi Hamadani; Navneet S Majhail; Alpana A Waghmare; Nelson Chao; Nicolaus Kröger; Bronwen Shaw; Mohamad Mohty; Dietger Niederwieser; Hildegard Greinix; Shahrukh K Hashmi Journal: Biol Blood Marrow Transplant Date: 2020-07-24 Impact factor: 5.742
Authors: Suzy Morton; Mallika Sekhar; Heather Smethurst; Ana Mora; Renate L Hodge; Cara L Hudson; Joseph Parsons; Valerie Hopkins; Simon J Stanworth Journal: Haematologica Date: 2022-06-01 Impact factor: 11.047