Distal Radius FracturesPhase 4TRADRNCT06384456
Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation
A Phase 4 study testing Topical TRanexamic Acid in people with Distal Radius Fractures, run by University Health Network, Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Topical TRanexamic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 13 Aug 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario
Ryan Paul, MD, 416-603-5641, ryan.paul2@uhn.ca
About this study
Official title: The Effect of Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following Distal Radius Fracture Fixation: a Randomized Controlled Trial - The TRADR Study
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
- Being tested
- Topical TRanexamic Acid, Placebo
- Keywords
- Distal Radius Fractures, acute pain, Topical tranexamic acid, Open Reduction and Internal FIxation, Placebo, Randomized Control Trial
- Medical subject headings
- Wrist Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical TRanexamic AcidDrug
10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.
PlaceboDrug
10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.
| Study group | Role | What they receive |
|---|---|---|
| Topical TRanexamic Acid | Experimental | 10mL of 100mg/mL TXA in addition to the standard care Receives: Drug: Topical TRanexamic Acid |
| Placebo | Placebo comparator | 10mL of 100mg/mL normal saline in addition to the standard care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute post-op pain
It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.
Measured: 24 hours to 72 hours postoperatively
Secondary outcomes (4)
opioid use
Opioid use will be recorded on patients' medication diary
Measured: 1, 2, and 6-week post-surgery
persistent pain
It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.
Measured: 1, 2, and 6-week post-surgery
unscheduled hand-related procedures
clinic/emergency unit visits or any issue or events related to the condition that might lead participant to visit the emergency room, be seen by a doctor, or undergo any intervention more frequently than the usual visits
Measured: 1, 2, and 6-week post-surgery
Patient reported function
will be assessed using the disabilities of the arm, shoulder and hand questionnaire (DASH) score 0 to 100, with higher score indicating more disability.
Measured: 1, 2, and 6-week post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start13 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Paul, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384456
- Sponsor's protocol ID
- 23-5708
- Acronym
- TRADR
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lameire DL, Noori A, Abbas A, Persitz J, Baltzer H, Collett E, Veillette C, Chan A, Paul R. The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre - The TRADR study. BMJ Open. 2025 May 21;15(5):e095684. doi: 10.1136/bmjopen-2024-095684.
PubMed 40398932
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following Distal Radius Fracture Fixation: a Randomized Controlled Trial - The TRADR Study
- ClinicalTrials.gov ID
- NCT06384456
- Acronym / sponsor ID
- TRADR / 23-5708
- Conditions
- Distal Radius Fractures
- Keywords
- Distal Radius Fractures, acute pain, Topical tranexamic acid, Open Reduction and Internal FIxation, Placebo, Randomized Control Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Apr 2024 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical TRanexamic Acid | Experimental | Drug: Topical TRanexamic Acid10mL of 100mg/mL TXA in addition to the standard care |
| Placebo | Placebo comparator | Drug: Placebo10mL of 100mg/mL normal saline in addition to the standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Topical TRanexamic Acid10mL of 100mg/mL TXA will be administered into the surgical wound prior closure. | Drug | Topical TRanexamic Acid |
| Placebo10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure. | Drug | Placebo |
Primary outcome
acute post-op pain
Time frame: 24 hours to 72 hours postoperatively
It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.
4 secondary outcomes
opioid use
Time frame: 1, 2, and 6-week post-surgery
persistent pain
Time frame: 1, 2, and 6-week post-surgery
unscheduled hand-related procedures
Time frame: 1, 2, and 6-week post-surgery
Patient reported function
Time frame: 1, 2, and 6-week post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 40398932Lameire DL, Noori A, Abbas A, Persitz J, Baltzer H, Collett E, Veillette C, Chan A, Paul R. The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre - The TRADR study. BMJ Open. 2025 May 21;15(5):e095684. doi: 10.1136/bmjopen-2024-095684.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical TRanexamic Acid in people with Distal Radius Fractures, run by University Health Network, Toronto at 1 site 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Paul (416-603-5839, jhanna.bermudez@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute post-op pain (time frame: 24 hours to 72 hours postoperatively). 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 NCT06384456, which also lists 1 linked publication.
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 4 May 2026.