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

• Sponsor: Aswan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03880604
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myoma	Procedure: Triple tourniquets; Drug: TA; Other: placebo to TA	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A double-blinded randomized placebo-controlled trialA double-blinded randomized placebo-controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: A double-blinded randomized placebo-controlled trial
• Primary Purpose: Prevention
• Official Title: Triple Tourniquets With or Without IV Tranexamic Acid for Reducing Blood Loss at Open 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: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Triple tourniquets plus TA 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; 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; Other Names: Active comparator ; Drug: TA; 1-gram tranexamic acid (10 ml) in 100 ml saline infusion; Other Names: Active Comparator
Active Comparator: Triple tourniquets plus placebo to TA 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; 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; Other Names: Active comparator ; Other: placebo to TA; placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion; Other Names: placebo comparator

Outcome Measures

Primary Outcome Measures

1. Mean amount of intraoperative blood loss [intraoperative]

   measure the mean amount of intraoperative blood loss by gravimetric methods

Secondary Outcome Measures

1. The number of patients needs for blood transfusion [24 hours post delivery]

   Calculation the number of patients needs for blood transfusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 sallam, 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: NCT03880604
• Other Study ID Numbers: aswu/207/19
• First Posted: Mar 19, 2019
• Last Update Posted: May 13, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by hany farouk, Principal Investigator, Aswan University Hospital: Haemostatic tourniquets; tranexamic acid; myomectomy
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of May 13, 2019