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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Myoma

Intervention / Treatment
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* Drug: Topical TA
* Drug: vasopressin
* Other: placebo to TA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blinded randomized controlled stud
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure will be Mean amount of blood loss | 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 | calculate the number of the patients need of blood transfusion | 24 hours post delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal myomectomy, tranexamic acid, vasopressin