POC - Transfusion Algorithm Cardiac Study

NCT02200419 | Completed DMC

• 1 other identifier: 14-7495-A
• Study Type: interventional
• Target: 7,402
• Locations: 1 country
• Sites: 12

Brief 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?

Conditions

Heart Diseases

Keywords

Rotem; Point of care coagulation tests; Cardiac surgery; Vascular surgery; Cardiopulmonary bypass; Blood products; Transfusion; Viscoelastic coagulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Transfusion

  7 days

• Blood loss

  24 hours

• Ventilation and hospital stay

  24 hours to 7 days

• Kidney injury

  48 hours

• Post operative complications

  7 days

Study Arms (1)

Transfusion Algorithm

OTHER

Hospitals will be randomized to the intervention arm of the study in a stratified manner.

Other: POC-based transfusion algorithm

Interventions

POC-based transfusion algorithm OTHER

A transfusion algorithm based on point-of-care coagulation testing.

Transfusion Algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (12)

Dr. Charles McAdams

Calgary, Alberta, T2N 2T9, Canada

Location

Blaine Achen

Edmonton, Alberta, Canada

Location

Dr. Terry Waters

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Dr. Sukhpal Brar

Vancouver, British Columbia, Canada

Location

Dr. H. Grocott

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Dr. Summer Syed

Hamilton, Ontario, L8N 3Z5, Canada

Location

Dr. Christopher Harle

London, Ontario, N6A 5A5, Canada

Location

Dr. Daniel Kim

Newmarket, Ontario, L3Y 2P9, Canada

Location

Dr. D. Tran

Ottawa, Ontario, K1Y 4W7, Canada

Location

Dr. F. Moussa

Toronto, Ontario, M4N 3M5, Canada

Location

Dr. E. Medicis

Fleurimont, Quebec, J1H 5N4, Canada

Location

Dr. J. Bussieres

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Karkouti K, Callum J, Wijeysundera DN, Rao V, Crowther M, Grocott HP, Pinto R, Scales DC; TACS Investigators. Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial. Circulation. 2016 Oct 18;134(16):1152-1162. doi: 10.1161/CIRCULATIONAHA.116.023956. Epub 2016 Sep 21.

  PMID: 27654344 DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Keyvan Karkouti, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: July 25, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

CA (12)