POC - Transfusion Algorithm Cardiac Study

Heart Diseases Clinical Trial

— TACS  

Official title:

Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200419
• Other study ID #: 14-7495-A
• Status: Completed
• Phase: N/A
• First received: June 20, 2014
• Last updated: December 1, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

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?

Description:

Despite major advances in cardiac surgery, coagulopathy continues to carry a heavy burden in cases that require the use of cardiopulmonary bypass (CPB), occurring frequently and resulting in excessive blood loss, blood product transfusions, and adverse clinical outcomes. Current management of coagulopathy is hampered by the inability of conventional laboratory tests to delineate its etiology in a timely manner, thereby precluding timely and targeted transfusion therapy. With the advent of point-of-care (POC) coagulation tests that can rapidly identify the etiology of coagulopathy, it may now be possible to reduce the burden of coagulopathy and thereby reduce transfusions and adverse outcomes. Several single-centre studies (including one by the investigator group) have found that the use of POC-based algorithms in cardiac surgery can markedly reduce blood product transfusions and by that means reduce morbidities and mortality.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Other:
• POC-based transfusion algorithm
A transfusion algorithm based on point-of-care coagulation testing.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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