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

Last updated: May 10, 2019
Sponsor: Aswan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Fibroids

Treatment

N/A

Clinical Study ID

NCT03880604
aswu/207/19
  • Ages 20-45
  • Female

Study 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

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 100
Study Start date:
April 01, 2019
Estimated Completion Date:
July 01, 2021

Study 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

Connect with a study center

  • Aswan University Hospital

    Aswan, 81528
    Egypt

    Active - Recruiting

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