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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03880604

Acronym

TTT

Enrollment

100

Registered

2019-03-19

Start date

2019-04-01

Completion date

2021-07-01

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myoma

Keywords

Haemostatic tourniquets, tranexamic acid, myomectomy

Brief 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

Interventions

PROCEDURETriple 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

DRUGTA

1-gram tranexamic acid (10 ml) in 100 ml saline infusion

OTHERplacebo to TA

placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

A double-blinded randomized placebo-controlled trial

Intervention model description

A double-blinded randomized placebo-controlled trial

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean amount of intraoperative blood loss	intraoperative	measure the mean amount of intraoperative blood loss by gravimetric methods

Secondary

Measure	Time frame	Description
The number of patients needs for blood transfusion	24 hours post delivery	Calculation the number of patients needs for blood transfusion

Countries

Egypt

Contacts

Primary Contacthany f sallam, md

hany.farouk@aswu.edu.eg0102236052

Backup Contactnahla w shady, md

nahla.elsayed@aswu.edu.eg01092440504

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026