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

Myoma Clinical Trial

— TTT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880604
• Other study ID #: aswu/207/19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 0102236052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Myoma

Intervention

Procedure:
• Triple tourniquets
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

Drug:
• TA
1-gram tranexamic acid (10 ml) in 100 ml saline infusion

Other:
• placebo to TA
placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean amount of intraoperative blood loss	measure the mean amount of intraoperative blood loss by gravimetric methods	intraoperative
Secondary	The number of patients needs for blood transfusion	Calculation the number of patients needs for blood transfusion	24 hours post delivery