Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy

NCT ID: NCT03880045

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-06-01

Brief Summary

In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy

Detailed Description

Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported

Conditions

Myoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Topical TA plus vasopressin

Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%

Group Type: ACTIVE_COMPARATOR

Topical TA

Intervention Type: DRUG

A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%

vasopressin

Intervention Type: DRUG

intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy

placebo to TA plus vasopressin

Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid

Group Type: ACTIVE_COMPARATOR

vasopressin

Intervention Type: DRUG

intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy

placebo to TA

Intervention Type: OTHER

(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.

Interventions

Topical TA

A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%

Intervention Type: DRUG

vasopressin

intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy

Intervention Type: DRUG

placebo to TA

(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.

Intervention Type: OTHER

Other Intervention Names

Active comparator; Active Comparator; placebo comparator

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f allam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University Hospital

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f allam, md

Role: CONTACT

hany.farouk@aswu.edu.eg

0102236052 ext. 002

nahla w shady, md

Role: CONTACT

nahla.elsayed@aswu.edu.eg

01092440504 ext. 002

Facility Contacts

Hany F Sallam, MD

Role: primary

hany.farouk@aswu.edu.eg

0122336052 ext. 002

Nahla W Shady, MD

Role: backup

nahla.elsayed@aswu.edu.eg

01092440504 ext. 002

Other Identifiers

aswu/206/19

Identifier Type: -

Identifier Source: org_study_id