TACO-BEL-3: a feasibility study and a retrospective audit of diuretics for patients receiving blood transfusion at ten hospitals.
furosemide
randomized clinical trials
transfusion-associated circulatory overload
Journal
Vox sanguinis
ISSN: 1423-0410
Titre abrégé: Vox Sang
Pays: England
ID NLM: 0413606
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
revised:
03
07
2020
received:
07
03
2020
accepted:
08
08
2020
pubmed:
27
10
2020
medline:
29
6
2021
entrez:
26
10
2020
Statut:
ppublish
Résumé
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. 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. 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%. 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.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
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
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
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
CONCLUSIONS
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.
Substances chimiques
Diuretics
0
Furosemide
7LXU5N7ZO5
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
434-439Informations de copyright
© 2020 International Society of Blood Transfusion.
Références
Public Health Agency of Canada: Health Canada Transfusion Transmitted Injuries Surveillance System, 2006-2012 Report. Vol. 2016, 2014. http://www.phac-aspc.gc.ca/hcai-iamss/ttiss-ssit/index-eng.php
FDA Center for Biologics Evaluation & Research. Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2017. 2020. Retrieved from https://www.fda.gov/media/124796/download. February 9
Lieberma L, Maskens C, Cserti-Gazdewich C, et al.: A retrospective review of patient factors, transfusion practices, and outcomes in patients with transfusion-associated circulatory overload. Transfus Med Rev 2013; 27:206-212
Alam A, Lin Y, Lima A, et al.: The prevention of transfusion-associated circulatory overload. Transfus Med Rev 2013; 27:105-112
Clifford L, Jia Q, Subramanian A, et al.: Risk factors and clinical outcomes associated with perioperative transfusion-associated circulatory overload. Anesthesiology 2017; 12:409-418
Andrzejewski C, Casey MA, Popovsky MA: How we view and approach transfusion-associated circulatory overload: pathogenesis, diagnosis, management, mitigation, and prevention. Transfusion 2013; 53:3037-3047
Lin Y, Cohen R, Armali C, et al.: Transfusion-associated circulatory overload prevention: a retrospective observational study of diuretic use. Vox Sang 2018; 113:386-392
Bosboom JJ, Klanderman RB, Migdady Y, et al.: Transfusion-associated cardiac overload: a clinical perspective. Transfus Med Rev 2019; 33:69-77
Parmar N, Pendergrast J, Lieberman L, et al.: The association of fever with transfusion-associated circulatory overload. Vox Sang 2017; 112:70-78
Andrzejewski C Jr, Popovsky MA, Stec TC, et al.: Hemotherapy bedside biovigilance involving vital sign values and characteristics of patients with suspected transfusion reactions associated with fluid challenges: can some cases of transfusion associated circulatory overload have proinflammatory aspects? Transfusion 2012; 52:2310-2320
Jhund PS, McMurray JJ, Davie AP: The acute vascular effects of furosemide in heart failure. Br J Clin Pharmacol 2000; 50:9-13
ter Maaten JM, Dunning AM, Valente MA, et al.: Diuretic response in acute heart failure-an analysis from ASCEND-HF. Am Heart J 2015; 170:313-321
Tseng E, Spradbrow J, Cao X, et al.: An order set and checklist improve physician transfusion ordering practices to mitigate the risk of transfusion-associated circulatory overload. Transfus Med 2016; 26:104-110
Fry JL, Arnold DM, Clase CM, et al.: Transfusion premedication to prevent acute transfusion reactions: a retrospective observational study to assess current practices. Transfusion 2010; 50:1722-1730
AABB: Association Bulletin #15-02: Transfusion Associated Circulatory Overload. [monograph on the internet]. 2015; Available from: http://www.aabb.org/programs/publications/bulletins/Docs/ab15-02.pdf [Last accessed March 6, 2020]
Pendergrast J, Armali C, Cserti-Gazdewich C, et al.: Can furosemide prevent transfusion-associated circulatory overload? Results of a pilot, double-blind, randomized controlled trial. Transfusion 2019; 59:1997-2006
Popovsky M, Robillard P, Schipperus M, et al.Proposed standard definitions for surveillance of non infectious adverse transfusion reactions. International Society of Blood Transfusion, 2011. http://www.isbtweb.org/fileadmin/user_upload/Proposed_definitions_2011_surveillance_non_infectious_adverse_reactions_haemovigilance_incl_TRALI_correction_2013.pdf [Last accessed February 7, 2020]
Ponto LL, Schoenwald RD: Furosemide (frusemide). A pharmacokinetic/pharmacodynamic review (Part I). Clin Pharmacokinet 1990; 18:381-408
Sarai M, Tejani AM: Loop diuretics for patients receiving blood transfusions. Cochrane Database Syst Rev 2015; 2:CD010138
Roubinian NH, Hendrickson JE, Triulzi DJ, et al.: Incidence and clinical characteristics of transfusion-associated circulatory overload using an active surveillance algorithm. Vox Sang 2017; 112:56-63
Cockcroft DW, Gault MH: Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41