Montreal, April 19th, 2007 -- In its April 19th, 2007 edition, the New England Journal of Medicine published an article about the findings of a multi-center randomized clinical trial that compared transfusion strategies for patients in pediatric intensive care units. The study, led by Dr. Jacques Lacroix, a full professor in the Department of Pediatrics at the Université de Montréal and a pediatric intensivist as well as researcher at the CHU Sainte-Justine, a university hospital center, was conducted in 637 children in 19 intensive care units in Canada, England, Belgium and the USA.
Determining the Transfusion Requirements of Pediatric Patients
Before this study, entitled “TRIPICU (Transfusion Requirements for Patients in Pediatric Intensive Care Units),” no precise data were available to guide intensive care specialists when deciding about whether or not to transfuse critically ill children. In fact, up until now, the optimal threshold for transfusion using packed red blood cells in children admitted to intensive care was not known.
A previous study carried out in adult patients suggested that a restrictive transfusion strategy could provide a better outcome than a liberal strategy. However, the study was conducted prior to the introduction of new practices involving the systematic removal of leukocytes from packed red blood cells before storage.
Dr. Jacques Lacroix adopted a hypothesis that a restrictive transfusion strategy would be as safe as a liberal strategy in stable, critically ill children. The study enrolled 637 children whose hemoglobin concentration was below 9.5 g of hemoglobin per deciliter (dl) within 7 days after their admission to an intensive care unit; 320 were randomized to a group with a threshold for transfusion set at 7g/dl (restrictive strategy group) and 317 to a group with a threshold at 9,5g/dl (liberal strategy group). On the whole, the hemoglobin level in the restrictive strategy group were maintained 2.1 +- 0.2 g/dl below those of the liberal strategy group. Only leukocyte-reduced packed red cells were used in this study.
Children in the restrictive strategy group received 44% fewer transfusions than in the liberal strategy group. In fact, 174 children in the restrictive strategy group received no transfusions at all as compared with 7 patients in the liberal strategy group.
New or progressive multiple organ dysfunction occurred in 38 patients in the restrictive group as opposed to 39 patients in the liberal group (12% in each group). There were 14 deaths in each group within 28 days after randomization. Furthermore, none of the other outcomes analyzed, including adverse events, revealed any significant differences.
Dr. Jacques Lacroix and his team were able to demonstrate that a transfusion threshold of 7g/dl could reduce the need for transfusion in stable, critically ill children without increasing the possibility of adverse outcomes. The new data report the first evidence that a more pronounced level of anemia in certain stable pediatric intensive care patients can be tolerated without consequences on the clinical course. Moreover, the findings should lead to a more rational use of packed red blood cells and a reduction in the use of and exposure to blood products in pediatric intensive care patients.
In Dr. Jacques Lacroix's opinion, the study's findings should lead to major changes in transfusion practices for stable patients in pediatric intensive care units. Based on the basic principle of therapeutic decision-making, the study will first and foremost result in fewer unnecessary transfusions that could adversely affect outcomes and it will provide pediatric intensive care patients with better health care.
The TRIPICU study was supported by grants from the Canadian Institutes of Health Research and the Fonds de la recherche en santé du Québec.
About the CHU Sainte-Justine
The CHU Sainte-Justine is the largest mother-child university hospital center in Canada with 450 beds, 19,000 admissions and 260,000 outpatients per year. It is affiliated to the Université de Montréal. More than 4,000 employees work at Sainte-Justine. It is one of the four most important pediatric centers in North America. The CHU Sainte-Justine is by far the largest pediatric training center in Quebec and a leader in Canada with an enrollment of approximately 4,000 students per year. Sainte-Justine's Research Center receives about $25 million in grant funding per year. Sainte-Justine and its research center have earned a prestigious reputation worldwide. Sainte-Justine celebrates its centennial in 2007.
Journal
New England Journal of Medicine