Clinical trial NCT00470444: Transfusion Triggers in Cardiac Surgery
Official title: Transfusion Triggers in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Cardiac Surgery
Transfusion Medicine
Cardiac Anesthesia Risk Evaluation (CARE) Score of 3 or 4
(Dupuis J-Y et al, Anesthesiology 2001;94: 194-204)
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Blood Services
First posted: 2007-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A high proportion of patients having cardiac surgery receive red cell transfusions. Yet, the investigators do not know whether transfusions are beneficial and they may be associated with harm. It is thus important to determine when a transfusion is required. The investigators will conduct a small pilot study at St. Michael's Hospital to address this issue. Patients having cardiac surgery will be allocated to one of two transfusion strategies with endpoints being compliance with the transfusion strategy and clinical outcome. The results of this study will be used to design a large definitive multicentered trial of these two transfusion strategies.

Detailed description: The optimal hemoglobin concentrations for transfusion in the perioperative setting in patients having cardiac surgery have not been established, and red cell transfusion rates for these patients are high. In a recent retrospective study of seven Canadian centres, which included 11,812 cardiac surgical patients, 44% of patients received one or more red cell units, and the range of patients transfused was 28% to 60%. As morbidity and mortality may be dependent on the severity of anemia and administration of transfusions, it is essential to determine at what hemoglobin concentration physicians should be transfusing these patients, particularly because the efficacy of transfusion has not been established. However, as any definitive trial will require thousands of patients, and as there is variability in transfusion practices, preliminary studies need to be completed to ensure the feasibility of adherence to proposed transfusion strategies. This pilot study is the first of two pilot trials designed to address the question of optimum hemoglobin concentrations for transfusion in patients having cardiac surgery prior to undertaking a definitive randomized controlled trial. The purpose of this study is to determine adherence to transfusion strategies.

Eligibility criteria: Inclusion Criteria:

* Care Score of 3/4 or age \>/= 80
* Signed informed consent

Exclusion Criteria:

* Patients who refuse participation
* Unable to or refuse blood products
* Involved in an autologous pre-donation program

Primary outcomes:
measure: Overall adherence to the transfusion strategies defined as adherence to the transfusion strategies in 90% of patients in more than 90% of their days in hospital.
timeFrame: Day of surgery through to hospital discharge.
Secondary outcomes:
measure: 1) enrollment rates 2) proportion of missing data 3) indicators for hypoxemia 4) mean number of red cell units used 5) clinical outcomes
timeFrame: Day of surgery through to hospital discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, University of Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dupuis JY, Wang F, Nathan H, Lam M, Grimes S, Bourke M. The cardiac anesthesia risk evaluation score: a clinically useful predictor of mortality and morbidity after cardiac surgery. Anesthesiology. 2001 Feb;94(2):194-204. doi: 10.1097/00000542-200102000-00006.
citation: Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
citation: Shehata N, Burns LA, Nathan H, Hebert P, Hare GM, Fergusson D, Mazer CD. A randomized controlled pilot study of adherence to transfusion strategies in cardiac surgery. Transfusion. 2012 Jan;52(1):91-9. doi: 10.1111/j.1537-2995.2011.03236.x. Epub 2011 Jul 25.