Tranexamic Acid for Wound Complications

(TXA in TAR Trial)

CR
CR
Overseen ByClinical Research Coordinator, BSc
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tranexamic acid, a medication that reduces bleeding, can improve wound healing after ankle replacement surgery. The goal is to determine if this drug can reduce complications such as delayed healing, wound opening, or infections. Participants will receive either tranexamic acid or a placebo (a saltwater solution) during their surgery, and neither they nor their doctors will know which one they received. This pilot study aims to assess the feasibility of a larger study and whether tranexamic acid could enhance patient recovery. Suitable candidates have undergone or are planning ankle replacement surgery and can attend follow-up visits. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tranexamic acid (TXA) is generally safe for use during surgery. Studies have found that most people tolerate TXA well, experiencing only mild or moderate side effects, while serious reactions remain rare in clinical trials. TXA effectively reduces bleeding and complications during surgeries. For instance, one study found that bleeding issues decreased from about one-third of cases to just 4% with TXA use. Another study demonstrated that applying TXA directly to wounds is both effective and safe.

Although TXA is mainly approved for treating heavy menstrual bleeding and assisting people with hemophilia, its use in surgeries, even those not involving the heart, has been shown to lower the risk of bleeding. This suggests that TXA could improve wound healing and recovery by reducing blood loss and swelling. Overall, existing research supports the safety of TXA in surgical settings.12345

Why do researchers think this study treatment might be promising?

Tranexamic acid (TXA) is unique because it offers a dual approach to reducing wound complications by both intravenous and topical administration. Unlike traditional treatments that mainly focus on systemic administration, TXA is applied directly to the wound site through a soaked sponge, potentially enhancing its effectiveness at controlling bleeding and improving healing. Researchers are excited about TXA because this combined delivery method could lead to better localized effects, reducing the risk of bleeding and complications more efficiently than standard treatments.

What evidence suggests that tranexamic acid might be an effective treatment for wound complications after total ankle replacement surgery?

Research has shown that tranexamic acid (TXA), which participants in this trial may receive, can greatly reduce bleeding during surgery. Studies have found that TXA decreases surgical blood loss by about one-third compared to a placebo. Surgeons have successfully used it in various procedures to reduce bleeding and swelling, aiding wound healing. In foot and ankle surgeries, TXA has lowered bleeding and fluid drainage after surgery, potentially aiding wound healing. While TXA effectively controls bleeding, more research is needed to confirm its specific benefits for wound healing in total ankle replacement surgeries.46789

Who Is on the Research Team?

BM

Bradley Meulenkamp, MD MSc FRCSC

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have total ankle replacement surgery at The Ottawa Hospital. People with certain medical conditions or who are not suitable for TXA may be excluded, but the main group is those having this specific ankle surgery.

Inclusion Criteria

I am willing and able to follow rehab and attend all follow-up visits.
The patient is willing and able to provide written informed consent
My surgeon believes surgery would benefit me.
See 1 more

Exclusion Criteria

Pregnant or breastfeeding patient
I am taking medications that may interact with tranexamic acid and increase heart attack risk.
Use of lateral-based ankle replacement system
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total ankle replacement surgery and receive either TXA or placebo

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including wound healing and complications

6 months
Routine follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Tranexamic Acid

Trial Overview

The study compares tranexamic acid (TXA), a medicine that reduces bleeding, to a placebo (salt water) in patients having ankle replacement surgery. Patients are randomly assigned to one of the two groups and neither they nor their doctors know which treatment they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TXAExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Citations

Efficacy of Tranexamic Acid in Reducing Blood Loss During ...

Evidence suggests that TXA can reduce surgical blood loss by nearly one-third compared to placebo [20]. In the context of burn surgery, TXA may ...

Topical Tranexamic Acid Use Amongst Surgical Specialties

The findings demonstrate that the use of topical TXA effectively reduces postoperative bleeding and drain output without significantly increasing the occurrence ...

Safety and Efficacy of Tranexamic Acid in General Surgery

prophylactic TXA significantly reduced major bleeding events (8.0% vs 10.5%) without significant differences in safety events (11.9% vs 12.5%) ...

Tranexamic Acid May Promote Wound Healing by ...

The results demonstrated that TXA reduced blood loss by an average 277.51 mL (95% CI, –410.47 to –144.5; P = 0.00) compared with placebo, and ...

Clinical use of tranexamic acid: evidences and controversies

Tranexamic acid (TXA) significantly reduces blood loss in a wide range of surgical procedures and improves survival rates in obstetric and trauma patients ...

Safety and Efficacy of Local Tranexamic Acid for the ... - PMC

Safety and Efficacy of Local Tranexamic Acid for the Prevention of Surgical Bleeding in Soft-Tissue Surgery: A Review of the Literature and Recommendations ...

Perioperative Tranexamic Acid Reduces Bleeding and ...

Patients receiving TXA experienced substantially fewer bleeding complications, with event rates decreasing from approximately one-third of cases to about 4%, ...

Topical tranexamic acid for prophylaxis of bleeding

Our findings to date indicate that the application of 25 mg/ml tranexamic acid on wound surfaces is both effective and safe. In our studies, we ...

Tranexamic Acid - StatPearls - NCBI Bookshelf

The only FDA-approved indications for tranexamic acid (TXA) are heavy menstrual bleeding and short-term prevention in patients with hemophilia.