Winnipeg Site

  • Brett Houston

    Assistant Professor, Hematologist, and Clinician-Scientist at the University of Manitoba and CancerCare Manitoba

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  • Ryan Zarychanski

    Associate Professor, Critical Care physician, Hematologist, and Clinician-Scientist at the University of Manitoba and CancerCare Manitoba

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 Trial Synopsis

 

Title:

A Phase IV trial of a hospital policy of Tranexamic acid use to reduce transfusion in major non-cardiac surgery (TRACTION)

Short title:

Tranexamic acid to reduce transfusion in major surgery

Trial Design:

Pragmatic, randomized cluster-crossover trial.

Planned Sample Size of Trial Participants:

Approximately 8320 patients 18 years of age and with Increased local fibrinolysis undergoing surgeries known to have a baseline transfusion rate of 5% or greater.

Investigational Medicinal Product(s):

Tranexamic acid (TXA)

Formulation, Dose, Route of Administration:

TXA 1 gram intravenous bolus followed by 1 additional gram prior to skin closure.

 

Formulation, Dose, Route of Administration:

TXA 1 gram intravenous bolus followed by 1 additional gram prior to skin closure.Treatment

Duration:

From first surgical incision until skin closure (or 8h).

Follow Up Duration:

90 day

Planned Trial Period:

1 year

Primary Outcomes:

Co-primary outcomes include: a) the proportion of patients transfused red blood cells (RBCs); and b) the incidence of deep vein thrombosis or pulmonary embolus within 3 months of surgery.

Secondary Outcomes:

(1) Transfusion: The number of RBC units transfused, both at an individual-level and at a cluster-level; (2) Safety: In-hospital diagnosis of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolus; (3) Clinical: Hospital length of stay, ICU admission, hospital survival, 3-month survival, and the number of days at home to day 30 (DAH30); 4) Compliance: proportion of eligible patients who receive the policy intervention, and the policy compliance in enrolled patients.

 
TRACTION Protocol

 Trial Sites

 

HEALTH SCIENCES CENTRE | WINNIPEG, MB

Principal Investigator:  Dr. Ryan Zarychanski | Dr. Brett Houston | Thomas Mutter | Dr. Craig Haberman

Research Coordinator:  Nora Choi 

ST BONIFACE HOSPITAL | WINNIPEG, MB

Principal Investigator:  Dr. Ryan Zarychanski | Dr. Hema Bagry

Research Coordinator:  Quinn Tays

GRACE GENERAL HOSPITAL | WINNIPEG, MB

Principal Investigators:  Dr. Jayesh Daya

Research Coordinator:  TBD

OTTAWA HOSPITAL | OTTAWA, ON

Principal Investigators:  Dr. Dean Fergusson | Dr. Daniel McIssac | Dr. Rodney Breau

Research Coordinator: Melissa Tessier

HEALTH SCIENCES NORTH | SUDBURY,ON

Principal Investigator:  Dr. Sarah McIssac | Dr. Kaitlin Duncan

Research Coordinator: TBD

KINGSTON GENERAL HOSPITAL | KINGSTON, ON

Principal Investigator:  Dr. Tarit Saha

Research Coordinator:  Debbie DuMerton | Elorm Vowotor

HÔPITAL MONTFORT | OTTAWA, ON

Principal Investigator:  Dr. Meghan Andrews

Research Coordinator:  Melodie Potvin | Christine Compas