[Apr.14, 2023: Staff Writer, The Brighter Side of News]
The study is the first of its kind to answer the longstanding question in transfusion medicine about the possible impact of donor gender. (CREDIT: Creative Commons)
A groundbreaking clinical trial involving more than 8,700 patients has revealed that the gender of a blood donor does not affect the survival of recipients of red blood cell transfusions. The study, which was published in the New England Journal of Medicine, is the first of its kind to answer the longstanding question in transfusion medicine about the possible impact of donor gender on recipient survival.
Previous observational studies had suggested that female donor blood might be linked to a higher risk of death among recipients compared to male donor blood. However, the clinical trial, which was conducted by a team of researchers from The Ottawa Hospital, Centre hospitalier de l'Université de Montréal, and Université de Montréal, found no evidence to support this claim.
Dr. Dean Fergusson, co-lead author of the study and senior scientist at The Ottawa Hospital, Director of the hospital’s Clinical Epidemiology Program, and professor at the University of Ottawa, said, “Some observational studies had suggested female donor blood might be linked with a higher risk of death among recipients compared to male donor blood, but our clinical trial found that isn’t the case.”
The American National Heart, Lung and Blood Institute identified the possible impact of the gender of a blood donor on recipient survival as a research priority in 2015. However, the results of previous observational studies have been conflicting. To answer this question definitively, a large, randomized clinical trial was required, but such studies are incredibly expensive.
Dr. Michaël Chassé, co-lead author of the study and intensivist at Centre hospitalier de l'Université de Montréal and associate professor at Université de Montréal, said, “By embedding this trial in real-world practice and using practical methods, we answered this question for a fraction of what a trial would normally cost.”
The research team estimates that using typical trial methods, this trial would have cost $9 million, but with their innovative approach, it only cost $300,000.
The approach involved enrolling every adult patient at The Ottawa Hospital who might need a transfusion, randomizing them to receive male or female blood, and then collecting data from existing hospital databases and provincial registries.
Dr. Dean Fergusson holding a unit of blood. (CREDIT: The Ottawa Hospital)
As male and female blood were considered equivalent treatments, patients did not need to provide written consent to join the trial but were given the option to opt out after the first transfusion. With this pragmatic approach, the team was able to enroll 8,719 participants into their double-blind, randomized trial in just over two years.
The study did not include patients without an Ontario Health Insurance Plan number, those who were massively bleeding and needed blood right away, and those with a complex antibody profile that made blood unit matching difficult.
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.
Dr. Michaël Chassé, co-lead author of the study and intensivist at Centre hospitalier de l'Université de Montréal and associate professor at Université de Montréal. (CREDIT: CHUM)
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.”
The baseline hemoglobin level before transfusion was 79.5±19.7 g per liter, and patients received a mean of 5.4±10.5 units of red cells in the female donor group and 5.1±8.9 units in the male donor group. (CREDIT: New England Journal of Medicine)
Dr. Dean Fergusson, co-lead author of the study, emphasized the importance of these findings. "Our study provides strong evidence that the gender of the blood donor does not have any impact on the survival of recipients of red blood cell transfusions. This is important because it means that blood banks and hospitals can focus on other factors when selecting blood for transfusions, such as blood type and compatibility."
Dr. Michaël Chassé, the other co-lead author, also highlighted the cost-effectiveness of the study's approach. "By using a pragmatic approach, we were able to answer this question for a fraction of what a trial would normally cost. This means that more resources can be allocated towards other important research questions in transfusion medicine."
The study's results have been welcomed by blood banks and hospitals around the world. Dr. Jason Acker, a senior scientist at Canadian Blood Services, described the findings as "very important" and expressed hope that they would encourage more eligible donors to donate blood. "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," he said.
The study's methodology has also been praised for its innovative approach. By embedding the trial in real-world practice and using existing hospital databases and provincial registries, the researchers were able to enroll over 8,700 participants into their double-blind, randomized trial in just over two years.
The study's findings are likely to have broader implications for transfusion medicine research. Dr. Fergusson noted that the study's approach could be used to answer other important questions in the field. "This study shows that pragmatic trials can be an effective way to answer important questions in transfusion medicine," he said. "We believe that this approach could be used to answer other research questions in the field, such as the optimal storage conditions for blood products."
Dr. Chassé also emphasized the potential of pragmatic trials in transfusion medicine research. "Pragmatic trials offer a cost-effective and efficient way to answer important questions in transfusion medicine," he said. "We hope that this study will inspire others to use this approach to answer other important questions in the field."
The study's results have been widely reported in the media and have generated significant interest among healthcare professionals and the general public. The New England Journal of Medicine, which published the study, has described it as "an important contribution to the field of transfusion medicine."
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