NCT06384456 Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation
| NCT ID | NCT06384456 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Health Network, Toronto |
| Condition | Distal Radius Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2025-08-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06384456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distal Radius Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06384456 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06384456 currently recruiting?
Yes, NCT06384456 is actively recruiting participants. Contact the research team at jhanna.bermudez@uhn.ca for enrollment information.
Where is the NCT06384456 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06384456 clinical trial?
NCT06384456 is sponsored by University Health Network, Toronto. The trial plans to enroll 90 participants.