Heart Diseases Clinical Trial
— TACSOfficial title:
Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial
This multi-centre study will provide sound, generalizable data on the effectiveness of a
POC-based algorithm to determine to what extent this guideline can reduce blood product
transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at
10 participating hospitals. The proposed trial addresses several important research and
clinical issues and has the potential to markedly improve the transfusion management and
surgical care in general of cardiac surgery patients.
The intervention will be a novel POC-based algorithm that has been shown in a pilot study by
us to be associated with a substantial reduction in blood product transfusions. The
algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of
blood loss. The primary outcome will be avoidance of red blood cell transfusion during
hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate.
Secondary outcomes will include avoidance of red blood cell use and other blood products
(plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse
clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data
will also be collected for future health-economics analyses.
Largely due to the limitations of existing evidence, however, such algorithms are rarely
used in clinical practice. The proposed trial will provide sound, generalizable data on the
effectiveness of a POC-based algorithm to guide their future use. An integrated blood
management algorithm that employs POC coagulation tests will reduce blood product
transfusions in cardiac surgery, thereby improving clinical outcomes.
Does an integrated blood transfusion algorithm that employs POC coagulation tests applied
across a network of hospitals reduce blood transfusions and associated adverse outcomes in
cardiac surgery?
Status | Completed |
Enrollment | 7402 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Hospital Inclusion: - Participating hospitals must not currently be using a POC-based blood conservation algorithm; must have an in-hospital RBC transfusion rate of > 35% and platelet or plasma transfusion rates of > 20%; must conduct > 600 cardiac surgeries employing CPB per year; and must have commitments from departments of Anesthesia, Cardiac Surgery, and Laboratory Medicine to support the study and to abide by the algorithm - Blood transfusion algorithm instituted as standard-of-care at participating hospitals - All adult (= 18 years) patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) will be included in the analysis. Exclusion Criteria: Hospitals not meeting inclusion. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Dr. Charles McAdams | Calgary | Alberta |
Canada | Blaine Achen | Edmonton | Alberta |
Canada | Dr. E. Medicis | Fleurimont | Quebec |
Canada | Dr. Summer Syed | Hamilton | Ontario |
Canada | Dr. Christopher Harle | London | Ontario |
Canada | Dr. Daniel Kim | Newmarket | Ontario |
Canada | Dr. D. Tran | Ottawa | Ontario |
Canada | Dr. J. Bussieres | Sainte -Foy | Quebec |
Canada | Dr. F. Moussa | Toronto | Ontario |
Canada | Dr. Sukhpal Brar | Vancouver | British Columbia |
Canada | Dr. Terry Waters | Vancouver | British Columbia |
Canada | Dr. H. Grocott | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Point Of Care (POC) Transfusion Algorithm Cardiac Study | The primary outcome measure will be the proportion of patients who receive any allogeneic red blood cell (RBC) transfusion from admission before surgery to end of follow-up. | 2.5 years | No |
Secondary | Transfusion | Allogeneic blood products (platelets, plasma, cryoprecipitate) or coagulation factors (e.g., fibrinogen concentrate, factor VIIa), or undergo re-exploration; units of blood products transfused, nadir hemoglobin concentration (to identify changes in transfusion practice that may be unrelated to treatment of coagulopathy) | 7 days | No |
Secondary | Blood loss | Chest-tube drainage at 6 and 24 hours after surgery | 24 hours | No |
Secondary | Ventilation and hospital stay | Duration of mechanical ventilation and length of stay in the ICU and hospital | 24 hours to 7 days | No |
Secondary | Kidney injury | Incidence of acute kidney injury, defined as a = 2-fold in increase in creatinine or new renal replacement therapy within 48 hours after surgery | 48 hours | No |
Secondary | Post operative complications | Arrhythmias, sternal infection, myocardial infarction, stroke, thromboembolic events, and death | 7 days | No |
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