Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy

What Was Tested

In this not phased trial, researchers set out to test Vasopressin.

It had two arms (groups): Topical TA plus vasopressin (active comparator) and placebo to TA plus vasopressin (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy.

Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration.

Who Took Part

100 planned participants were the target.

It was open to women only aged from 20 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging. Age ≥ 18 years and ≤ 50 years. Ability to understand and the willingness to sign a written informed consent. Admissible medical/surgical history. Five or less symptomatic uterine myomas.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: patients who have had a prior abdominal myomectomy; post-menopausal women; patients with known bleeding/clotting disorders.

How the Study Was Run

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

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-04-01 with completion listed for 2021-03-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: measure will be Mean amount of blood loss (time frame: intraoperative).

It also tracked 1 secondary outcome, for example the number of the patients need of blood transfusion.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 100 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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