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

Primary Purpose

Myoma

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Triple tourniquets
TA
placebo to TA
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myoma focused on measuring Haemostatic tourniquets, tranexamic acid, myomectomy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Aswan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triple tourniquets plus TA

Triple tourniquets plus placebo to TA

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean amount of intraoperative blood loss
measure the mean amount of intraoperative blood loss by gravimetric methods

Secondary Outcome Measures

The number of patients needs for blood transfusion
Calculation the number of patients needs for blood transfusion

Full Information

First Posted
March 15, 2019
Last Updated
May 10, 2019
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03880604
Brief Title
Triple Tourniquets With or Without Tranexamic Acid for Reducing Blood Loss at Open Myomectomy
Acronym
TTT
Official Title
Triple Tourniquets With or Without IV Tranexamic Acid for Reducing Blood Loss at Open Myomectomy: A Double-blinded Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma
Keywords
Haemostatic tourniquets, tranexamic acid, myomectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A double-blinded randomized placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A double-blinded randomized placebo-controlled trial
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triple tourniquets plus TA
Arm Type
Active Comparator
Arm Description
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
Arm Title
Triple tourniquets plus placebo to TA
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Triple tourniquets
Other Intervention Name(s)
Active comparator
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TA
Other Intervention Name(s)
Active Comparator
Intervention Description
1-gram tranexamic acid (10 ml) in 100 ml saline infusion
Intervention Type
Other
Intervention Name(s)
placebo to TA
Other Intervention Name(s)
placebo comparator
Intervention Description
placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion
Primary Outcome Measure Information:
Title
Mean amount of intraoperative blood loss
Description
measure the mean amount of intraoperative blood loss by gravimetric methods
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
The number of patients needs for blood transfusion
Description
Calculation the number of patients needs for blood transfusion
Time Frame
24 hours post delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All women who prepared for abdominal myomectomies will be invited to participate in the study
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam, md
Phone
0102236052
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
nahla w shady, md
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany f Sallam, MD
Phone
0122336052
Ext
002
Email
hany.farouk@aswu.edu.eg
First Name & Middle Initial & Last Name & Degree
Nahla W Shady, MD
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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