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

Trial Summary

What is the purpose of this trial?

Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery.

Research Team

Ann Tran, MD

Principal Investigator

Mount Sinai Hospital & Medical Center

Gokhan Kilic, MD

Principal Investigator

University of Texas Medical Branch Galveston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+