Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy

Study Overview
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Brief Summary
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In this study, the investigators will investigate the effectiveness of an intravenous tranexamic acid plus triple tourniquets compared with triple tourniquets alone for the reduction of blood loss at the time of myomectomy

Detailed Description
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An RCT investigated the efficacy of intravenous tranexamic acid (TA) during abdominal myomectomy. The study was unable to demonstrate any significant impact on blood loss, duration of surgery or need for blood transfusionHemostatic tourniquets to reduce intra-operative bleeding have long been available, but data on their efficacy from controlled trials are lacking. The investigators set out to evaluate the use of triple tourniquets plus tranexamic acid in controlled conditions and for the first time to investigate the hypothesis that adding tranexamic acid to tourniquet around the uterine artery reduces postoperative bleeding from the uterine incisions, a well-recognized sequel to surgery

Official Title
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Triple Tourniquets With or Without IV Tranexamic Acid for Reducing Blood Loss at Open Myomectomy: A Double-blinded Randomized Placebo-controlled Trial

Conditions
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Myoma

Intervention / Treatment
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* Procedure: Triple tourniquets
* Drug: TA
* 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 placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triple tourniquets plus TA<br>A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus1-gram tranexamic acid (10 ml) in 100 ml saline infusion | Procedure: Triple tourniquets<br>* A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels<br>* Other names: Active comparator;Drug: TA<br>* 1-gram tranexamic acid (10 ml) in 100 ml saline infusion<br>* Other names: Active Comparator;|
| Active Comparator: Triple tourniquets plus placebo to TA<br>A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels.plus placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion | Procedure: Triple tourniquets<br>* A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels<br>* Other names: Active comparator;Other: placebo to TA<br>* placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion<br>* Other names: placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of intraoperative blood loss | measure the mean amount of intraoperative blood loss by gravimetric methods | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients needs for blood transfusion | Calculation the number of patients needs for 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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Haemostatic tourniquets, tranexamic acid, myomectomy