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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Health Sciences Centre Foundation, Manitoba | OTHER |
| The Ottawa Hospital | OTHER |
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A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.
The TRACTION Trial is a national multi-centre Phase IV randomized cluster-crossover trial of Tranexamic acid versus placebo. Over the duration of the study, participating centres will be centrally and randomly allocated to receive either TXA or matching placebo at 1-month intervals. As our pragmatic trial is designed to define practice, we have selected co-primary outcomes that evaluate effectiveness in the context of safety.
Our co-primary outcomes are the:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid (TXA) Arm | Active Comparator | TXA 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure). |
|
| Placebo Arm | Placebo Comparator | Placebo 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid (TXA) | Drug | TXA 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients transfused RBCs | Proportion of patients requiring transfused RBCs | From date of surgery until the date of hospital discharge, assessed up to 90 days |
| Incidence of DVT or PE (collectively called venous thromboembolism (VTE) | Number of patients with VTE events | Within 90 days of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Transfused units | The number of RBC units transfused (both at hospital level and patient level). | From date of surgery until 3 days post-operative, 7 days post-operative, and until the date of hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. |
| Arterial event - myocardial infarction |
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Cluster-level inclusion criteria:
Hospital sites will be included in the trial if the site performs ≥ 100 noncardiac surgeries per month, and if anesthesia, surgery and hospital leadership agree to manage patients as per the policy being implemented and evaluated in the trial.
Patient-level inclusion criteria:
Examples of eligible surgeries could include (but are not limited to):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Zarychanski, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada | ||
| University of Manitoba- HSC Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42267805 | Derived | Houston BL, McIsaac DI, Breau RH, Kanji S, Greenstreet P, Andrews M, Avramescu S, Bagry HS, Balshaw R, Daya J, Duncan K, Harle CC, Jacobsohn E, Kerelska T, Pitz M, Komenda P, McIsaac S, Ramsay T, Saha T, Tinmouth A, Recio A, Szoke D, Tenenbein M, Slagerman S, Solvason D, Talarico R, Fergusson DA, Zarychanski R. Hospital Policy of Tranexamic Acid to Reduce Transfusion in Major Noncardiac Surgery. N Engl J Med. 2026 Jun 10. doi: 10.1056/NEJMoa2515820. Online ahead of print. | |
| 38830735 |
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There are no plans to share individual participant data to other researchers.
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TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.
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Over the duration of the study, participating centres will be centrally and randomly allocated to receive either TXA or matching placebo at 1-month intervals for a total of 8 months. Intervention assignment will only be known to the research pharmacy staff who will prepare the study drug specific to the interval assignment. To minimize sources of selection and ascertainment biases, anesthesiologists, surgeons, investigators, research staff, and members of the Data Safety and Monitoring Board will all be blinded to randomization schemes and treatments administered; only the trial statistician will have access to randomization schemes for all sites. The research site's Pharmacy staff will not have contact with the study team or the patient and will be expressly forbidden to discuss individual treatment allocation with the study team, the patient, the operating room and clinical care team unless emergency un-blinding is warranted.
|
| Placebo (0.9 % Saline) | Drug | Placebo (0.9 % normal saline) 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure). |
|
Secondary safety outcomes include the in-hospital diagnosis of myocardial infarction |
| Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. |
| Arterial event - stroke | Secondary safety outcomes include the in-hospital diagnosis of stroke | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. |
| Venous thrombotic event - deep vein thrombosis | Secondary safety outcomes include the in-hospital diagnosis of deep vein thrombosis | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. |
| Venous thrombotic event - pulmonary embolus | Secondary safety outcomes include the in-hospital diagnosis of pulmonary embolus | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. |
| Length of hospitalization | Hospital length of stay | Length of index hospital admission |
| Intensive care unit (ICU) admission | Proportion of participants requiring ICU admission | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. |
| Hospital survival | Proportion of patients alive at hospital discharge | Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days. |
| 90 day survival | Survival at 90-days post-operative | Up to day 30 |
| Compliance | The proportion of enrolled patients who receive a minimum of one dose of the study intervention | Intraoperative |
| Clinical -a patient centered outcome | Number of days alive and out of hospital 30 (a patient-centered outcome, that integrates length of stay, readmission and early deaths after surgery into a single outcome metric | Up to day 30 postoperative |
| Winnipeg |
| Manitoba |
| R3E 0W2 |
| Canada |
| Grace Hospital | Winnipeg | Manitoba | R3J 3M7 | Canada |
| Health Sciences North Research Institute | Greater Sudbury | Ontario | P3E 5J1 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Ottawa Hospital Research Institute- General Campus | Ottawa | Ontario | K1H8L6 | Canada |
| Hôpital Montfort | Ottawa | Ontario | K1K 0T2 | Canada |
| Ottawa Hospital Research Institute- Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| Humber River Hospital | Toronto | Ontario | M3M 0B2 | Canada |
| Derived |
| Houston BL, McIsaac DI, Breau RH, Andrews M, Avramescu S, Bagry H, Balshaw RF, Daya J, Duncan K, Harle C, Jacobsohn E, Kerelska T, McIsaac S, Ramsay T, Saha T, Perelman I, Recio A, Solvason D, Szoke D, Tenenbein M, Fergusson DA, Zarychanski R. Hospital policy of tranexamic acid to reduce transfusion in major non-cardiac surgery (TRACTION): protocol for a phase IV randomised controlled trial. BMJ Open. 2024 Jun 3;14(6):e084847. doi: 10.1136/bmjopen-2024-084847. |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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