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

May 10, 2019 updated by: hany farouk, Aswan University Hospital

Topical Tranexamic Acid Plus Perivascular Vasopressin to Decrease Bleeding at the Time of Abdominal Myomectomy: A Double-blinded Randomized Placebo-controlled Trial

In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy

Study Overview

Status

Unknown

Conditions

Detailed Description

Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Aswan, Egypt, 81528
        • Recruiting
        • Aswan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
  • Age ≥ 18 years and ≤ 50 years
  • Pre-operative hemoglobin >8 g/dl
  • Ability to understand and the willingness to sign a written informed consent.
  • Admissible medical/surgical history
  • Five or less symptomatic uterine myomas
  • All myomas are subserous or intramural.
  • Uterine size less than 24 weeks of pregnancy

Exclusion Criteria:

  • Patients who have had a prior abdominal myomectomy
  • Post-menopausal women
  • Patients with known bleeding/clotting disorders
  • Patients with a history of gynecologic malignancy
  • Hypertension.
  • Cardiac and Pulmonary Diseases.
  • Obesity (body mass index > 30 kg/m2).
  • History of allergic reactions attributed to misoprostol
  • Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topical TA plus vasopressin
Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%
A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%
Other Names:
  • Active comparator
intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy
Other Names:
  • Active Comparator
Active Comparator: placebo to TA plus vasopressin
Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid
intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy
Other Names:
  • Active Comparator
(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.
Other Names:
  • placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure will be Mean amount of blood loss
Time Frame: intraoperative
measure will be Mean amount of blood loss by gravimetric methods
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of the patients need of blood transfusion
Time Frame: 24 hours post delivery
calculate the number of the patients need of blood transfusion
24 hours post delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: hany f allam, md, Aswan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Anticipated)

March 30, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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