NCT03880604

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Myoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-03-30
• Completion: 2021-07-01
• First posted: 2019-03-19
• Last updated: 2019-05-13

Locations

1 site across 1 country: Egypt