Newswise —
A study involving over 8,700 patients, which was published in the New England Journal of Medicine, has found that the gender of blood donors does not impact the survival rate of recipients who undergo red blood cell transfusions.
According to Dr. Dean Fergusson, a senior scientist at The Ottawa Hospital, Director of the hospital's Clinical Epidemiology Program, and professor at the University of Ottawa, previous observational studies had suggested a potential association between female donor blood and increased risk of death among recipients compared to male donor blood. However, the recent clinical trial involving over 8,700 patients contradicts these findings, concluding that the sex of the blood donor does not have any significant effect on the survival of recipients who undergo red blood cell transfusions.
The potential influence of the sex of a blood donor on the survival of recipients has been a topic of inquiry in the field of transfusion medicine since 2015, when it was identified as a research priority by the American National Heart, Lung, and Blood Institute. Some studies had indicated that sex-related differences, such as hormone levels in male and female blood, could impact the survival of recipients. However, the findings from observational studies have been inconsistent and have not provided a definitive answer to this question.
Dr. Michaël Chassé, who served as a co-lead author of the study and is an intensivist at Centre hospitalier de l'Université de Montréal and an associate professor at Université de Montréal, highlighted that answering this question definitively required a large randomized clinical trial, which can be prohibitively expensive. However, the study was able to provide valuable insights by incorporating the trial into real-world clinical practice and utilizing practical methods, resulting in a significant cost reduction compared to traditional clinical trials. This approach allowed for a more cost-effective way to obtain meaningful results and shed light on the impact of blood donor sex on recipient survival.
The research team estimated that the traditional trial methods for this study would have incurred a cost of $9 million. However, their innovative approach resulted in a significantly reduced cost of $300,000. The approach involved enrolling all eligible adult patients at The Ottawa Hospital who might require a blood transfusion, randomly assigning them to receive either male or female blood, and then collecting data from existing hospital databases and provincial registries. As both male and female blood were considered equivalent treatments, patients were not required to provide written consent to participate in the trial, but were given the option to opt out after the first transfusion. This pragmatic approach allowed the team to successfully enroll 8,719 participants in a double-blind, randomized trial within a timeframe of just over two years.
The study had certain limitations, including the exclusion of patients without an Ontario Health Insurance Plan (OHIP) number, as well as those who required immediate blood transfusions due to massive bleeding or had complex antibody profiles that posed challenges in blood unit matching. These exclusions may have impacted the generalizability of the study's findings to these specific patient populations. It is important to consider these limitations when interpreting the results and applying them to clinical practice, as they may not fully represent the broader population of patients receiving blood transfusions in all clinical scenarios. Further research may be needed to investigate the impact of blood donor sex on recipient survival in these excluded patient populations.
Study participants were randomly assigned to receive either male or female donor blood at all visits to The Ottawa Hospital during the study period. Eighty per cent of patients received their first transfusion while they were an inpatient, and 42 per cent of those received it during surgery.
Patient characteristics, laboratory and clinical data, and blood bank data were obtained from The Ottawa Hospital Data Warehouse. Blood donor data from Canadian Blood Services was linked with hospital data and health administrative data at ICES.
The study found no statistically significant differences in overall survival between recipients of male donor blood and recipients of female donor blood.
“Blood is the most common life-saving treatment given in hospital,” said Dr. Jason Acker, senior scientist at Canadian Blood Services. “As a blood provider, we were happy to help answer this very important question in transfusion medicine. We hope the findings encourage all eligible donors to continue to donate.”
Full reference: The effect of donor sex on recipient mortality in transfusion. Michaël Chassé, Dean A Fergusson, Alan Tinmouth, Jason P Acker, Iris Perelman, Angie Tuttle, Shane English, Steven Hawken, Alan J Forster, Nadine Shehata, Kednapa Thavorn, Kumanan Wilson, Nancy Cober, Heather Maddison, Melanie Tokessy. New England Journal of Medicine. April 12, 2023.
Funding: This study was funded by the Canadian Institutes of Health Research. All research at The Ottawa Hospital is also enabled by generous donors to The Ottawa Hospital Foundation.
Core resources: Ottawa Methods Centre, The Ottawa Hospital Data Warehouse, ICES
About The Ottawa Hospital
The Ottawa Hospital is one of Canada’s top learning and research hospitals, where excellent care is inspired by research and driven by compassion. As the third-largest employer in Ottawa, our support staff, researchers, nurses, physicians, and volunteers never stop seeking solutions to the most complex health-care challenges. Our multi-campus hospital, affiliated with the University of Ottawa, attracts some of the most influential scientific minds from around the world. Backed by generous support from the community, we are committed to providing the world-class, compassionate care we would want for our loved ones. www.ohri.ca
About the University of Ottawa
The University of Ottawa is home to over 54,000 students, faculty and staff, who live, work and study in both French and English. Our campus is a crossroads of cultures and ideas, where bold minds come together to inspire game-changing ideas. We are one of Canada’s top 10 research universities—our professors and researchers explore new approaches to today’s challenges. One of a handful of Canadian universities ranked among the top 200 in the world, we attract exceptional thinkers and welcome diverse perspectives from across the globe. www.uottawa.ca
About the CRCHUM
The University of Montreal Hospital Research Centre (CRCHUM) is one of North America’s leading hospital research centres. It strives to improve adult health through a research continuum covering such disciplines as the fundamental sciences, clinical research and public health. Over 2,300 people work at the CRCHUM, including more than 500 researchers and more than 520 graduate students. chumontreal.qc.ca/crchum @CRCHUM
About Université de Montréal
Deeply rooted in Montreal and dedicated to its international mission, Université de Montréal is one of the top universities in the French-speaking world. Founded in 1878, Université de Montréal today has 13 faculties and schools, and together with its two affiliated schools, HEC Montréal and Polytechnique Montréal, constitutes the largest centre of higher education and research in Québec and one of the major centres in North America. It brings together 2,400 professors and researchers and has more than 67,000 students. umontreal.ca
ICES is an independent, non-profit research institute that uses population-based health information to produce knowledge on a broad range of health care issues. Our unbiased evidence provides measures of health system performance, a clearer understanding of the shifting health care needs of Ontarians, and a stimulus for discussion of practical solutions to optimize scarce resources. ICES knowledge is highly regarded in Canada and abroad, and is widely used by government, hospitals, planners, and practitioners to make decisions about care delivery and to develop policy. In October 2018, the institute formerly known as the Institute for Clinical Evaluative Sciences formally adopted the initialism ICES as its official name. For the latest ICES news, follow us on Twitter: @ICESOntario
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