Tranexamic Acid in Vaginal Reconstructive Surgery

What Was Tested

In this phase 4 trial, researchers set out to test Vasopressin.

There are no studies regarding the use of TXA in urogynecology.

The registry classes the interventions as drug and other.

More on the Plan

Each participating site will obtain IRB approval.

Women with symptomatic, stage II to IV Pelvic organ prolapse (POP) who plan colpocleisis will be approached to participate.

Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined.

All eligible subjects will provide the written informed consent before any research data is collected.

Who Took Part

It was open to women only aged from 50 years up to 100 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Females who are menopausal at the time of consent. 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. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: refusal of blood products (e.g, jehovah's witnesses); ASA physical status III or IV; known allergy or hypersensitivity to txa or any of the ingredients.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

The Vasopressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-07-01 with completion listed for 2025-01-27.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Intraoperative quantitative blood loss QBL (mL) (time frame: Intraoperatively).

It also tracked 5 secondary outcomes, for example Colpocleisis operative time (min), Intraoperative blood pressure (mmHg), Intraoperative hear rate (beats/min), Postoperative complications and Rate of transfusion.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vasopressin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.