90 Participants Needed

Topical Tranexamic Acid for Wrist Fractures

(TRADR Trial)

RP
Overseen ByRyan Paul
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University Health Network, Toronto
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the drug Tranexamic Acid when applied topically for wrist fractures?

Research shows that applying Tranexamic Acid directly to surgical wounds can reduce bleeding in various surgeries, like knee and hip surgeries, without causing extra complications. This suggests it might also help reduce bleeding in wrist fractures.12345

How is the drug Tranexamic Acid unique for treating wrist fractures?

Topical Tranexamic Acid is unique because it is applied directly to the skin over the fracture, which may help reduce bleeding without the need for systemic (whole-body) administration, as seen in other surgeries like knee replacements.13456

Eligibility Criteria

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
See 8 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Topical TRanexamic AcidExperimental Treatment1 Intervention
10mL of 100mg/mL TXA in addition to the standard care
Group II: PlaceboPlacebo Group1 Intervention
10mL of 100mg/mL normal saline in addition to the standard care

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Findings from Research

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.
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.
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.
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]

References

Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. [2022]
Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. [2021]
Bleeding reduction after topical application of tranexamic acid together with Betadine solution in total knee arthroplasty. A randomised controlled study. [2018]
Topical administration of tranexamic acid in elderly patients undergoing short femoral nailing for intertrochanteric fracture: A randomised controlled trial. [2022]
Topical tranexamic acid reduces transfusion rates in simultaneous bilateral total knee arthroplasty: a retrospective case series. [2022]
The effect of topical and systemic tranexamic acid on fracture healing in rats. [2020]