Tranexamic Acid for Prolapse

(TEXAS Trial)

Overseen By Trieu H Do, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Anti-epileptics

Disqualifiers: Thromboembolic disease, Cardiac diseases, Cancer, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effectiveness and safety of tranexamic acid (TXA) during vaginal reconstructive surgery for pelvic organ prolapse (POP), a condition where pelvic organs drop due to weak support muscles, causing discomfort or pressure. Researchers will compare TXA with vasopressin and a placebo (a harmless substitute) to determine which best reduces blood loss. The trial seeks menopausal women with POP symptoms who plan to undergo colpocleisis surgery for treatment. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective TXA can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have epilepsy or seizure disorders requiring anti-epileptic medications, you cannot participate in the trial.

What is the safety track record for these treatments?

Research has shown that tranexamic acid (TXA) is commonly used to reduce blood loss in surgeries, such as trauma and heart surgeries. Studies indicate that TXA is generally safe, with most people experiencing no serious side effects.

Evidence suggests that TXA can reduce blood loss by over 25% in surgeries like hysterectomies without causing major issues. Although specific studies on TXA in urogynecology are lacking, its approval for other surgeries suggests it is likely safe.

For those considering joining a trial using TXA, these findings suggest it should be safe based on its use in other surgeries. Always consult your healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Tranexamic Acid for treating pelvic organ prolapse because it offers a potentially more targeted approach to managing bleeding during colpocleisis surgery. Unlike standard treatments, which often involve general hemostatic agents or mechanical methods to control bleeding, Tranexamic Acid works by specifically inhibiting enzymes that break down blood clots, potentially reducing blood loss with precision. Additionally, the local infiltration of Tranexamic Acid directly into the vaginal submucosa is a novel delivery method that could enhance its effectiveness right at the site where it's needed. This targeted application could lead to quicker recovery times and fewer complications for patients undergoing prolapse surgery.

What evidence suggests that this trial's treatments could be effective for prolapse?

Research has shown that tranexamic acid (TXA) reduces blood loss in surgeries such as trauma, bone, heart, and plastic surgeries. Numerous strong studies support this, and TXA is frequently used in these operations to control bleeding. However, no published research specifically addresses TXA's effectiveness in urogynecology surgeries, such as vaginal reconstructive surgery. In this trial, one group of participants will receive TXA to evaluate its effectiveness in reducing blood loss during colpocleisis dissection. Evidence from other surgeries suggests that TXA could be useful in this new area. ^{1 2 3 4 6}

Who Is on the Research Team?

Gokhan Kilic, MD

Principal Investigator

University of Texas Medical Branch Galveston

Ann Tran, MD

Principal Investigator

Mount Sinai Hospital & Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing vaginal reconstructive surgery due to pelvic organ prolapse. Specific eligibility criteria are not provided, but typically participants would need to be in good health and meet certain medical standards set by the study.

Inclusion Criteria

Able to understand and read English

Able and willing to provide written informed consent

Able to comply with the follow-up study protocol, per clinician judgment

Exclusion Criteria

Texas Department of Criminal Justice prisoners

I refuse blood transfusions due to personal beliefs.

I have had a bleeding in the space around my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-8 weeks

1 visit (in-person)

Treatment

Participants undergo colpocleisis with local infiltration of Tranexamic Acid, Vasopressin, or Normal Saline

Intraoperative

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for postoperative complications and recovery

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic Acid

Trial Overview The trial investigates if Tranexamic acid (TXA), which reduces blood loss in various surgeries, is also effective and safe when used locally during vaginal reconstructive surgery. It compares TXA with standard treatments like NaCl 0.9% and Vasopressin.

How Is the Trial Designed?

Group I: Vasopressin (0.1 U/dL) Experimental Treatment 1 Intervention

Local infiltration of 50 cc Vasopressin (0.1 U/dL) into the vaginal submucosa during colpocleisis dissection

Group II: Tranexamic Acid (2 mg/dL) Experimental Treatment 1 Intervention

Local infiltration of 50 cc Tranexamic Acid (2 mg/dL) into the vaginal submucosa during colpocleisis dissection

Group III: Normal Saline (NaCl 0.9%) Placebo Group 1 Intervention

Local infiltration of 50 cc NaCl 0.9% into the vaginal submucosa during colpocleisis dissection

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

MOUNT SINAI HOSPITAL

Collaborator

Trials

44

Recruited

17,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39814219/

Does Intravenous Tranexamic Acid Reduce Blood Loss at ... This study showed no statistically significant differences in blood loss outcomes with the use of IV TXA at the time of total colpocleisis (±midurethral ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S155346502500024X

Does Intravenous Tranexamic Acid Reduce Blood Loss at ... This study showed no statistically significant differences in blood loss outcomes with the use of IV TXA at the time of total colpocleisis (±midurethral sling).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03216083

Does Intravenous Tranexamic Acid Reduce Blood Loss ... Recent RCTs on its use in benign hysterectomy, as well as in advanced ovarian cancer surgery have shown a decrease in blood loss of more than 25% without an ...

4. jmig.org jmig.org/article/S1553-4650(25)00024-X/pdf

Does Intravenous Tranexamic Acid Reduce Blood Loss at ... 1. This study found that intravenous tranexamic acid (TXA) did not significantly reduce blood loss or the need for transfusions in women undergoing total ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06419075

Tranexamic Acid in Vaginal Reconstructive Surgery Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and ...

6. withpower.com withpower.com/trial/phase-4-pelvic-organ-prolapse-6-2024-ee6c7

Tranexamic Acid for Prolapse (TEXAS Trial) ... Tranexamic Acid will have tolerable side effects & efficacy for patients with Pelvic Organ Prolapse and Pelvic Organ Prolapse. Learn more about the study.