Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy

April 20, 2020 updated by: Ahmed Samy aly ashour, Cairo University

Comparative Safety and Efficacy of Intravenous Tranexamic Acid Versus IV Carbetocin in Reducing Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial

the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

153

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging

Exclusion Criteria:

  • women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intravenous tranexamic acid
The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision
Drug: intravenous tranexamic acid
The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision
Active Comparator: intravenous carbetocin
The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision
Drug: intravenous carbetocin
The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision
Placebo Comparator: placebo
the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision
Drug: placebo
the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative blood loss
Time Frame: one hour
the intraoperative blood loss in ml will be estimated during the procedure
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for blood transfusion
Time Frame: 24 hours
need for intraoperative or postoperative blood transfusion
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

October 10, 2020

Study Completion (Anticipated)

October 20, 2020

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tranexamic acid myomectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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