Topical Tranexamic Acid for Wrist Fractures

(TRADR Trial)

Overseen By Ryan Paul

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University Health Network, Toronto

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Chronic pain, Pregnancy, Cardio-respiratory, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate postoperative period (up to 72 hours)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if topical tranexamic acid (TXA), applied during wrist surgery, can reduce pain, decrease the need for painkillers, and improve wrist function post-surgery. Participants will receive either TXA or a placebo (a harmless substance) for comparison. Ideal candidates are those undergoing surgery to fix a wrist fracture, with no history of chronic pain conditions or current opioid use. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants (blood thinners) in time for surgery, following specific guidelines. If you are currently using opioids, you cannot participate in the trial.

What is the safety track record for topical tranexamic acid?

Research shows that tranexamic acid (TXA) is generally safe for people. Studies have found that using TXA on the skin or as a single intravenous dose is well-tolerated, with a low risk of side effects. For example, in surgeries like total knee replacements, TXA effectively reduces post-surgery pain. Another study found that TXA can lower the risk of infections at the surgical site in heart surgeries.

While TXA usually controls bleeding, applying it to wounds during surgery has been linked to better recovery. The treatment is already in late-stage testing, having passed earlier safety checks. This suggests that using TXA on the skin is likely safe for reducing pain and improving recovery after wrist fracture surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for wrist fractures, which typically focus on immobilization, pain management, and sometimes surgery, topical tranexamic acid (TXA) offers a unique approach. TXA is applied directly to the skin and works by reducing bleeding and swelling around the fracture site due to its ability to prevent blood clots from breaking down too quickly. This localized application could potentially enhance healing and recovery time compared to more systemic treatments. Researchers are excited about this because it might offer a faster, more efficient way to manage wrist fractures, with fewer side effects than traditional oral or intravenous medications.

What evidence suggests that topical tranexamic acid might be an effective treatment for wrist fractures?

Research has shown that topical tranexamic acid (TXA) can help reduce pain after surgery. Studies have demonstrated that applying TXA directly to the surgical area significantly lessens pain for patients undergoing surgeries such as total knee replacements. Other studies have found that TXA also reduces pain after wrist fracture surgeries. In this trial, participants will receive either topical TXA or a placebo to evaluate its effectiveness in reducing pain and the need for painkillers after wrist fracture surgery. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing surgery for a wrist fracture. It aims to see if applying tranexamic acid (TXA) directly into the wound can reduce pain and improve wrist function post-surgery compared to a placebo.

Inclusion Criteria

Provision of informed consent

Cognitive ability and English-language skills required to complete outcome measures

I am having surgery for a wrist fracture using the volar approach.

Exclusion Criteria

I have a chronic pain condition, fibromyalgia, or polymyalgia rheumatica.

I had surgery on my wrist from the back of my hand.

Known allergic reaction to TXA

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either topical tranexamic acid or placebo during wrist fracture surgery

Immediate postoperative period (up to 72 hours)

Follow-up

Participants are monitored for pain, function, and opioid use post-surgery

6 weeks

Visits at 1, 2, and 6 weeks post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Topical Tranexamic Acid

Trial Overview

The study is testing topical tranexamic acid (TXA), applied to the surgical site, against a placebo. The focus is on measuring differences in post-operative pain, use of painkillers, and recovery of wrist function between the two groups.

How Is the Trial Designed?

Group I: Topical TRanexamic Acid Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

In a study involving 202 patients undergoing mastectomy, applying tranexamic acid (TXA) topically to the surgical wound significantly reduced postoperative bleeding, as indicated by lower drain production in the first 24 hours (110 ml vs. 144 ml for placebo).

The use of TXA also showed a trend towards fewer early hematomas compared to the placebo group (1 vs. 7), suggesting a potential benefit in reducing complications, while no significant differences in overall postoperative complications were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. Ausen, K., Hagen, AI., Østbyhaug, HS., et al.[2021]

In a study involving 125 patients undergoing total knee arthroplasty, the use of topical tranexamic acid (TXA) combined with povidone-iodine significantly improved postoperative hemoglobin levels and reduced blood loss compared to a control group that only received povidone-iodine.

The application of TXA did not lead to any significant complications, indicating that it is a safe and effective method to minimize bleeding during and after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bleeding reduction after topical application of tranexamic acid together with Betadine solution in total knee arthroplasty. A randomised controlled study. Carvalho, LH., Frois Temponi, E., Machado Soares, LF., et al.[2018]

In a study of 49 patients undergoing simultaneous bilateral total knee arthroplasty, the use of topical tranexamic acid (TA) significantly reduced the rate of blood transfusions from 67% to 4% and decreased net hemoglobin loss compared to those who did not receive TA.

Topical TA administration also led to a shorter postoperative hospital stay by an average of 1.1 days, with no increase in the risk of thromboembolic events, indicating its safety and efficacy in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical tranexamic acid reduces transfusion rates in simultaneous bilateral total knee arthroplasty: a retrospective case series. Kim, C., Park, SS., Dhotar, HS., et al.[2022]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40398932/

The effect of topical TRanexamic Acid versus placebo on ...

This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12097037/

The effect of topical TRanexamic Acid versus placebo on ...

Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty.

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The Effect of Topical TRanexamic Acid vs. placebo on Ac

Pain following Distal Radius Fracture Fixation: A Randomized Controlled Trial - The. TRADR Study. Principal Investigator: Dr. Ryan Paul, University of Toronto ...

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Topical TRanexamic Acid Vs. Placebo on Acute Postoperative ...

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 ...

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clinicaltrials.gov/study/NCT04907812

The Role of Tranexamic Acid in Reducing Post Operative ...

Distal radius fractures treated with additive or alternative approaches and fixation to the volar approach; Known history of lymphedema or lymph node dissection ...

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The emerging role of tranexamic acid and its principal ...

Regarding these effects on clinical outcomes, TXA treatment significantly reduced the rate of surgical site infection after cardiac surgery (RR = 0.70, 95% CI ...

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Current research progress of tranexamic acid in the ...

Tranexamic acid (TXA), an antifibrinolytic agent, has shown promise in reducing blood loss and improving outcomes in trauma patients.

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a protocol for a systematic review and network meta-analysis

The results showed that perioperative prophylactic topical use or single-dose intravenous TXA has high safety and a low incidence of adverse events.

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Tranexamic acid for the prevention and treatment of bleeding ...

The results showed an absolute mortality reduction of 1.5 % and a relative risk (RR) reduction of about 9 %; RR 0.91; 95 % CI [0.85–0.97]; p = ...