- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200419
POC - Transfusion Algorithm Cardiac Study (TACS)
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?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- Dr. Charles McAdams
-
Edmonton, Alberta, Canada
- Blaine Achen
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Dr. Terry Waters
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Vancouver, British Columbia, Canada
- Dr. Sukhpal Brar
-
-
Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- Dr. H. Grocott
-
-
Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- Dr. Summer Syed
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London, Ontario, Canada, N6A 5A5
- Dr. Christopher Harle
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Newmarket, Ontario, Canada, L3Y 2P9
- Dr. Daniel Kim
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Ottawa, Ontario, Canada, K1Y 4W7
- Dr. D. Tran
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Toronto, Ontario, Canada, M4N 3M5
- Dr. F. Moussa
-
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- Dr. E. Medicis
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Sainte -Foy, Quebec, Canada, G1V 4G5
- Dr. J. Bussieres
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Transfusion Algorithm
Hospitals will be randomized to the intervention arm of the study in a stratified manner.
|
A transfusion algorithm based on point-of-care coagulation testing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point Of Care (POC) Transfusion Algorithm Cardiac Study
Time Frame: 2.5 years
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transfusion
Time Frame: 7 days
|
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
|
Blood loss
Time Frame: 24 hours
|
Chest-tube drainage at 6 and 24 hours after surgery
|
24 hours
|
Ventilation and hospital stay
Time Frame: 24 hours to 7 days
|
Duration of mechanical ventilation and length of stay in the ICU and hospital
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24 hours to 7 days
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Kidney injury
Time Frame: 48 hours
|
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
|
Post operative complications
Time Frame: 7 days
|
Arrhythmias, sternal infection, myocardial infarction, stroke, thromboembolic events, and death
|
7 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-7495-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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