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

Sponsor

Aswan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03880045

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myoma	Drug: Topical TA Drug: vasopressin Other: placebo to TA	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A double-blinded randomized controlled studA double-blinded randomized controlled stud

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

A double-blinded randomized controlled stud

Primary Purpose:

Prevention

Official Title:

Topical Tranexamic Acid Plus Perivascular Vasopressin to Decrease Bleeding at the Time of Abdominal Myomectomy: A Double-blinded Randomized Placebo-controlled Trial

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Mar 30, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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%	Drug: Topical TA A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9% Other Names: Active comparator 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 Other Names: Active Comparator
Active Comparator: 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	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 Other Names: Active Comparator Other: placebo to TA (120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min. Other Names: placebo comparator

Arm

Intervention/Treatment

Active Comparator: 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%

Drug: Topical TA

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

Other Names:

Active comparator

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

Other Names:

Active Comparator

Active Comparator: 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

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

Other Names:

Active Comparator

Other: placebo to TA

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

Other Names:

placebo comparator

Outcome Measures

Primary Outcome Measures

measure will be Mean amount of blood loss [intraoperative]
measure will be Mean amount of blood loss by gravimetric methods

Secondary Outcome Measures

the number of the patients need of blood transfusion [24 hours post delivery]
calculate the number of the patients need of blood transfusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

Principal Investigator: hany f allam, md, Aswan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hany farouk, Principal Investigator, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT03880045

Other Study ID Numbers:

aswu/206/19

First Posted:

Mar 19, 2019

Last Update Posted:

May 13, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by hany farouk, Principal Investigator, Aswan University Hospital

abdominal myomectomy

tranexamic acid

vasopressin

Additional relevant MeSH terms:

Vasopressins

Arginine Vasopressin

Study Results

No Results Posted as of May 13, 2019