Tranexamic Acid for Urethral Stricture

(REDUCER Trial)

AA
Overseen ByAmjad Alwaal, MD, MSc, FACS
Age: 18+
Sex: Male
Trial Phase: Phase 4
Sponsor: Amjad Alwaal, MD, MSc, FRCSC, FACS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 (TXA), a medication that reduces bleeding, can lower blood loss during urethroplasty surgery. Urethroplasty repairs urethral stricture, a condition where the urethra narrows. Participants will either receive TXA during surgery or undergo the standard procedure without it. The study aims to determine if TXA can maintain hemoglobin levels and reduce complications. Individuals undergoing urethroplasty for urethral stricture who can provide informed consent might be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulants (blood thinners), you may need to stop them if they can't be safely held during the surgery period.

What is the safety track record for tranexamic acid?

Research has shown that tranexamic acid (TXA) is generally safe and well-tolerated in various surgeries. One study found that using TXA during prostate surgeries controlled blood loss without causing harmful side effects. Another study demonstrated that TXA reduced blood loss and maintained stable hemoglobin levels during these surgeries.

Some studies also noted that patients receiving TXA had shorter hospital stays and required less time with a Foley catheter, a tube used to drain urine. Overall, TXA appears safe, with no serious side effects reported in these studies. This information may reassure those considering joining a clinical trial involving TXA.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about tranexamic acid (TXA) for urethral stricture because it offers a new approach by potentially reducing bleeding during urethroplasty surgery, which is not something standard options like simple urethroplasty or dilation typically address. TXA works by stabilizing blood clots, which can lead to less blood loss and potentially quicker recovery times post-surgery. Unlike standard surgical treatments that focus on physically correcting the stricture, TXA adds a biochemical edge by targeting blood clotting processes, making it an innovative addition to surgical care.

What evidence suggests that tranexamic acid might be an effective treatment for reducing blood loss in urethroplasty?

This trial will compare tranexamic acid (TXA) with standard surgical care in participants undergoing urethroplasty. Studies have shown that TXA reduces blood loss during surgery. Research indicates that TXA can lower the risk of major bleeding by 3.4% in surgeries involving the urinary system. It also reduces the need for blood transfusions and improves surgical outcomes without increasing the risk of blood clots. A review of studies found that TXA helps control blood loss and maintains stable hemoglobin levels, which is crucial for healthy blood after surgery. Overall, TXA is considered effective for reducing bleeding during surgeries like urethroplasty.12678

Who Is on the Research Team?

AA

Amjad Alwaal, MD, MSc, FACS

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are scheduled to have urethroplasty surgery for a narrowed urethra (urethral stricture) and can give informed consent.

Inclusion Criteria

I am 18 years old or older.
I am having surgery to fix a blocked or narrowed urethra.
* Ability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous dose of tranexamic acid (TXA) at the start of anesthesia or standard care without TXA during urethroplasty

During surgery
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including routine clinical follow-up and assessment of postoperative complications

30 days
Routine clinical follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Tranexamic Acid
  • Urethroplasty

Trial Overview

The study tests if giving tranexamic acid (TXA), a medicine that helps reduce bleeding, at the start of anesthesia during urethroplasty surgery lowers blood loss compared to not using TXA. Participants are randomly assigned to receive TXA or standard care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Tranexamic Acid (TXA)Experimental Treatment1 Intervention
Group II: Standard of Care (No TXA)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amjad Alwaal, MD, MSc, FRCSC, FACS

Lead Sponsor

Citations

Impact of Tranexamic Acid for Hemostasis on Postoperative ...

This study aims to investigate the effects of intravenous tranexamic acid (TXA) hemostasis during pediatric hypospadias surgery on postoperative complications.

Tranexamic Acid Reduces Major Bleeding Risk in Urologic ...

In concluding remarks, Dr Tikkinen highlighted that TXA reduced the absolute risk of major bleeding by 3.4% — from 9.5% to 6.1%. The team did ...

Tranexamic Acid for Urethral Stricture (REDUCER Trial)

This study will test whether tranexamic acid (TXA), a medication used to reduce bleeding, can decrease blood loss in patients having urethroplasty.

The impact of tranexamic acid on perioperative outcomes in ...

TXA use may improve blood loss, transfusion rates, and perioperative parameters in urological procedures. In addition, there is no increased risk of VTE ...

Systematic Review and Meta-Analysis on the Effectiveness ...

The results showed that tranexamic acid is beneficial in reducing blood loss and minimising changes in haemoglobin levels during transurethral ...

Impact of intravesical administration of tranexamic acid on ...

In this study, it was observed that patients given intravesical TXA injection had shorter ED length of stay (P < 0.001) and duration of Foley catheter placement ...

Can high-dose tranexamic acid have a role during ...

High-dose TXA was effective in controlling blood loss during B-TURP in patients with large prostates, with no adverse drug reactions.

Tranexamic acid is beneficial for reducing perioperative blood ...

The results of the current study indicated that TXA could reduce intraoperative and 4 h postoperative blood loss resulting from TURP surgery, but it had no ...