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

NCT03880604 | Unknown DMC

• 1 other identifier: aswu/207/19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Myoma

Keywords

Haemostatic tourniquets; tranexamic acid; myomectomy

Outcome Measures

Primary Outcomes (1)

• Mean amount of intraoperative blood loss

  measure the mean amount of intraoperative blood loss by gravimetric methods

  intraoperative

Secondary Outcomes (1)

• The number of patients needs for blood transfusion

  24 hours post delivery

Study Arms (2)

Triple tourniquets plus TA

ACTIVE COMPARATOR

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; Drug: TA

Triple tourniquets plus placebo to TA

ACTIVE COMPARATOR

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; Other: placebo to TA

Interventions

Triple tourniquets PROCEDURE

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

Also known as: Active comparator

Triple tourniquets plus TA; Triple tourniquets plus placebo to TA

TA DRUG

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

Also known as: Active Comparator

Triple tourniquets plus TA

placebo to TA OTHER

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

Also known as: placebo comparator

Triple tourniquets plus placebo to TA

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: All women who prepared for abdominal myomectomies will be invited to participate in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Myoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

0102236052; hany.farouk@aswu.edu.eg

nahla w shady, md

CONTACT

01092440504; nahla.elsayed@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blinded randomized placebo-controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blinded randomized placebo-controlled trial

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: July 1, 2021
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)