Aditi Khandelwal1,2,3,4, Yulia Lin1,4,5, Christine Cserti-Gazdewich1,2,4, Muntadhar Al Moosawi6, Chantal Armali4,5, Donald Arnold7,8, Jeannie Callum2,4, Karen L Dallas6,9, Lani Lieberman1,2,4, Katerina Pavenski1,4,10, Benjamin Rioux-Massé11, Nadine Shehata2,3,4,12, Andrew W Shih6,13,14, Jacob Pendergrast1,2,4. 1. Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada. 2. Laboratory Medicine Program, University Health Network, Toronto, ON, Canada. 3. Canadian Blood Services, Toronto, ON, Canada. 4. Education and Safety in Transfusion (QUEST) Research Program, University of Toronto Quality in Utilization, Toronto, ON, Canada. 5. Sunnybrook Health Sciences Centre, Toronto, ON, Canada. 6. Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada. 7. Hamilton General Hospital, Hamilton, ON, Canada. 8. Juravinski Cancer Centre, Hamilton, ON, Canada. 9. St. Paul Hospital, Vancouver, BC, Canada. 10. St Michael's Hospital, Toronto, ON, Canada. 11. Centre Hospitalier de l'Université de Montréal, Montreal, PQ, Canada. 12. Mount Sinai Hospital, Toronto, ON, Canada. 13. Vancouver General Hospital, Vancouver, BC, Canada. 14. Centre for Blood Research, University of British Columbia, Vancouver, BC, Canada.
Abstract
BACKGROUND AND OBJECTIVES:Transfusion-associated circulatory overload (TACO) is the leading cause of transfusion-related morbidity and mortality. A recently completed pilot trial randomized patients to pre-transfusion furosemide versus placebo but had a slower than expected enrollment rate. We sought to determine whether the lack of recruitment was due to a paucity of eligible patients or excessively restrictive eligibility criteria. MATERIALS AND METHODS:At 10 sites, eligible patients were retrospectively identified by first screening blood bank databases over one month for all transfusion episodes meeting trial inclusion criteria, defined as non-surgical patients receiving single RBC unit transfusions. The age threshold was decreased from 65 to 50 years. The first 10 patients meeting inclusion criteria then underwent detailed chart review for the exclusion criteria. The incidence of TACO and furosemide use was also recorded. RESULTS: At the 10 sites, 11 969 red cell units were transfused over 1 month and 1356 met the inclusion criteria. Of the 100 charts reviewed, 60 (60%) had no exclusion criteria. Active bleeding was the most common reason for ineligibility. There were 813 eligible transfusion episodes. Of the eligible patients, 17 (28·3%) had evidence of congestive heart failure, and furosemide was prescribed in 24 (40%). Despite the use of a lower age threshold, three cases of TACO were detected with an incidence of 3%. CONCLUSION: A large number of transfusion episodes met eligibility criteria. With a 3% incidence of TACO, 50% decrease through the use pre-transfusion furosemide and a target consent rate of 30%, a definitive trial of approximately 3000 patients could be completed within 1 year.
RCT Entities:
BACKGROUND AND OBJECTIVES: Transfusion-associated circulatory overload (TACO) is the leading cause of transfusion-related morbidity and mortality. A recently completed pilot trial randomized patients to pre-transfusion furosemide versus placebo but had a slower than expected enrollment rate. We sought to determine whether the lack of recruitment was due to a paucity of eligible patients or excessively restrictive eligibility criteria. MATERIALS AND METHODS: At 10 sites, eligible patients were retrospectively identified by first screening blood bank databases over one month for all transfusion episodes meeting trial inclusion criteria, defined as non-surgical patients receiving single RBC unit transfusions. The age threshold was decreased from 65 to 50 years. The first 10 patients meeting inclusion criteria then underwent detailed chart review for the exclusion criteria. The incidence of TACO and furosemide use was also recorded. RESULTS: At the 10 sites, 11 969 red cell units were transfused over 1 month and 1356 met the inclusion criteria. Of the 100 charts reviewed, 60 (60%) had no exclusion criteria. Active bleeding was the most common reason for ineligibility. There were 813 eligible transfusion episodes. Of the eligible patients, 17 (28·3%) had evidence of congestive heart failure, and furosemide was prescribed in 24 (40%). Despite the use of a lower age threshold, three cases of TACO were detected with an incidence of 3%. CONCLUSION: A large number of transfusion episodes met eligibility criteria. With a 3% incidence of TACO, 50% decrease through the use pre-transfusion furosemide and a target consent rate of 30%, a definitive trial of approximately 3000 patients could be completed within 1 year.