Recruiting

TXA

Sponsor:

University Health Network, Toronto

Code:

NCT06384456

Conditions

Distal Radius Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Topical TRanexamic Acid

Placebo

Study Details

Brief summary:

The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo).

Conditions

Distal Radius Fractures

Study ID

NCT06384456

Start date

Aug 13, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture;
  • Aged 18 or older;
  • Provision of informed consent;
  • Cognitive ability and English-language skills required to complete outcome measures.

Exclusion Criteria:

  • Revision surgery or any additional operative management of ipsilateral wrist injury
  • Distal radius fracture treated with a dorsal approach
  • Known history of lymphedema or lymph node dissection in the operative extremity
  • Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic
  • Current user of opioids and/or on chronic opioids use
  • Known allergic reaction to TXA
  • Anticoagulant use not stopped in time for surgery as per thrombosis Canada guidelines (i.e. warfarin, acetylsalicylic acid, direct oral anticoagulants, etc.)
  • Previous thrombotic stroke or thromboembolic disorders (i.e. known previous DVT, PE, or clotting disorders)
  • Current pregnancy or breastfeeding
  • Previous neurologic injury causing paralysis of affected shoulder/arm
  • Severe cardio-respiratory disease (i.e. ASA Grade IV or higher).

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Topical TRanexamic Acid

10mL of 100mg/mL TXA in addition to the standard care

placebo comparator: Placebo

10mL of 100mg/mL normal saline in addition to the standard care

Interventions

Topical TRanexamic Acid

10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.

Placebo

10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.

Primary outcome measure

  • acute post-op pain [ Time Frame: 24 hours to 72 hours postoperatively ]

Central Contacts and Locations

Central contacts

Ryan Paul

416-603-5839jhanna.bermudez@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Ryan Paul, MD

416-603-5641ryan.paul2@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Distal Radius Fractures
  • acute pain
  • Topical tranexamic acid
  • Open Reduction and Internal FIxation
  • Placebo
  • Randomized Control Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-04.