Major Non-cardiac SurgeriesPhase 4TRACTIONNCT04803747
A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery
A Phase 4 study testing Tranexamic acid (TXA) in people with Major Non-cardiac Surgeries, run by University of Manitoba at 10 sites in Canada.
Trial summary
A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Non-cardiac Surgeries
- What is being tested?
- Tranexamic acid (TXA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,421 participants
- Where
- 10 sitesCanada
- Study dates
- 16 Feb 2022to 3 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Active thromboembolic disease (i.e., arterial or venous thrombosis within 90 days preoperative)
- Pregnancy
- Cardiac surgery and hip and knee arthroplasty where TXA is standard-of-care
- Surgeries with free flap reconstruction
- Trauma surgeries where TXA was administered within the previous 3 hours.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E 5J1
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5A5
Ottawa Hospital Research Institute- General Campus
Ottawa, Ontario, K1H8L6
Hôpital Montfort
Ottawa, Ontario, K1K 0T2
Ottawa Hospital Research Institute- Civic Campus
Ottawa, Ontario, K1Y 4E9
Humber River Hospital
Toronto, Ontario, M3M 0B2
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
University of Manitoba- HSC Campus
Winnipeg, Manitoba, R3E 0W2
Grace Hospital
Winnipeg, Manitoba, R3J 3M7
About this study
Official title: A Phase IV Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION): A Pragmatic Randomized Cluster Crossover Trial
A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.
Read the detailed description
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:
- Proportion of patients transfused RBCs
- Incidence of DVT or PE (collectively called venous thromboembolism (VTE) within 90 days of surgery.
- Conditions
- Major Non-cardiac Surgeries
- Being tested
- Tranexamic acid (TXA), Placebo (0.9 % Saline)
- Keywords
- Tranexamic acid (TXA), Venous thromboembolism (VTE), Deep vein thrombosis (DVT), Transfusion, Perioperative Bleeding
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Tranexamic acid (TXA) |
| 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). Receives: Drug: Placebo (0.9 % Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients transfused RBCs
Proportion of patients requiring transfused RBCs
Measured: 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
Measured: Within 90 days of surgery
Secondary outcomes (11)
Transfused units
The number of RBC units transfused (both at hospital level and patient level).
Measured: 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
Secondary safety outcomes include the in-hospital diagnosis of myocardial infarction
Measured: 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
Measured: 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
Measured: 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
Measured: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Length of hospitalization
Hospital length of stay
Measured: Length of index hospital admission
Intensive care unit (ICU) admission
Proportion of participants requiring ICU admission
Measured: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Hospital survival
Proportion of patients alive at hospital discharge
Measured: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
90 day survival
Survival at 90-days post-operative
Measured: Up to day 30
Compliance
The proportion of enrolled patients who receive a minimum of one dose of the study intervention
Measured: 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
Measured: Up to day 30 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start16 Feb 2022
- Primary completion5 Mar 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Non-cardiac SurgeriesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Sciences Centre Foundation, Manitoba, The Ottawa Hospital
- Responsible party
- Principal investigator, Dr. Ryan Zarychanski, University of Manitoba
- Investigators
- Ryan Zarychanski, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803747
- Sponsor's protocol ID
- TXA-51231
- Acronym
- TRACTION
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data to other researchers.
Publications
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 25;394(24):2419-2428. doi: 10.1056/NEJMoa2515820. Epub 2026 Jun 10.
PubMed 42267805Houston 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.
PubMed 38830735
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION): A Pragmatic Randomized Cluster Crossover Trial
- ClinicalTrials.gov ID
- NCT04803747
- Acronym / sponsor ID
- TRACTION / TXA-51231
- Conditions
- Major Non-cardiac Surgeries
- Keywords
- Tranexamic acid (TXA), Venous thromboembolism (VTE), Deep vein thrombosis (DVT), Transfusion, Perioperative Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,421 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Sciences Centre Foundation, Manitoba, The Ottawa Hospital
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.
Detailed description
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:
- Proportion of patients transfused RBCs
- Incidence of DVT or PE (collectively called venous thromboembolism (VTE) within 90 days of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid (TXA) Arm | Active comparator | Drug: Tranexamic acid (TXA)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 | Drug: Placebo (0.9 % Saline)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Active thromboembolic disease (i.e., arterial or venous thrombosis within 90 days preoperative)
- Pregnancy
- Cardiac surgery and hip and knee arthroplasty where TXA is standard-of-care
- Surgeries with free flap reconstruction
- Trauma surgeries where TXA was administered within the previous 3 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid (TXA)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). | Drug | Tranexamic acid (TXA) Arm |
| Placebo (0.9 % Saline)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). | Drug | Placebo Arm |
Primary outcome
Proportion of patients transfused RBCs
Time frame: From date of surgery until the date of hospital discharge, assessed up to 90 days
Proportion of patients requiring transfused RBCs
Incidence of DVT or PE (collectively called venous thromboembolism (VTE)
Time frame: Within 90 days of surgery
Number of patients with VTE events
11 secondary outcomes
Transfused units
Time frame: 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
Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Arterial event - stroke
Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Venous thrombotic event - deep vein thrombosis
Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Venous thrombotic event - pulmonary embolus
Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Length of hospitalization
Time frame: Length of index hospital admission
Intensive care unit (ICU) admission
Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
Hospital survival
Time frame: Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.
90 day survival
Time frame: Up to day 30
Compliance
Time frame: Intraoperative
Clinical -a patient centered outcome
Time frame: Up to day 30 postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 42267805Houston 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 25;394(24):2419-2428. doi: 10.1056/NEJMoa2515820. Epub 2026 Jun 10.
- Derived from this study: PubMed 38830735Houston 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.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data to other researchers.
Related trials for Major Non-cardiac Surgeries
Active, not recruiting
Individualized Versus Conventional Perioperative Blood Pressure Management
Major Non-cardiac Surgery
Not yet recruitingObservational study
Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study
Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
RecruitingObservational study
Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery
Acute Kidney Injury
Not yet recruitingObservational study
Preoperative Anxiety and Depression Among Older Chinese Patients
Depression, Anxiety
Not yet recruitingObservational study
The Impact of Preoperative Depression on Postoperative Delirium in Elderly Chinese Patients: A Retrospective Multicenter Observational Study
Cohort Studies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Zarychanski, MD principal investigator
University of Manitoba
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid (TXA) in people with Major Non-cardiac Surgeries, run by University of Manitoba at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients transfused RBCs (time frame: From date of surgery until the date of hospital discharge, assessed up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.