A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-16

Study Completion Date

2024-06-03

Brief Summary

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A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.

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Detailed Description

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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:

1. Proportion of patients transfused RBCs
2. Incidence of DVT or PE (collectively called venous thromboembolism (VTE) within 90 days of surgery.

Conditions

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Major Non-cardiac Surgeries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

TRACTION is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Tranexamic acid (TXA) Arm

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).

Group Type ACTIVE_COMPARATOR

Tranexamic acid (TXA)

Intervention Type 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 Arm

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).

Group Type PLACEBO_COMPARATOR

Placebo (0.9 % Saline)

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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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.

* Patients \>/= 18 years of age undergoing major non-cardiac surgery (a state of hyperfibrinolysis)
* Inpatient surgeries with an estimated \>/= 5% risk of RBC transfusion, including open surgeries or laparoscopic surgeries with an estimated duration of \>/= 3 hours

Examples of eligible surgeries could include (but are not limited to):

1. General surgery (esophagectomy, gastrectomy, gastric repair, small bowel repair or resection, ostomy formation, colon/rectum repair or resection, colostomy, splenectomy, hepatectomy, pancreatectomy, resection of abdominal mass)
2. Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation)
3. Spine (vertebrectomy, surgery involving \>/= 3 levels)
4. Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
5. Thoracic (lung resection or decortication)
6. Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta)
7. Gynecology (hysterectomy)
8. Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)
9. Plastic surgery (large neoplasm resections, burns or debridements)
10. Surgeries anticipated to be associated with 5% or greater risk of RBC transfusion in hospital as per the surgical team.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No