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

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ClinicalTrials.gov Identifier: NCT03880604
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 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 : April 1, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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 Name: Active comparator

Drug: TA
1-gram tranexamic acid (10 ml) in 100 ml saline infusion
Other Name: 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 Name: Active comparator

Other: placebo to TA
placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion
Other Name: placebo comparator




Primary Outcome Measures :
  1. Mean amount of intraoperative blood loss [ Time Frame: intraoperative ]
    measure the mean amount of intraoperative blood loss by gravimetric methods


Secondary Outcome Measures :
  1. The number of patients needs for blood transfusion [ Time Frame: 24 hours post delivery ]
    Calculation the number of patients needs for blood transfusion



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All women who prepared for abdominal myomectomies will be invited to participate in the study
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880604


Contacts
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Contact: hany f sallam, md 0102236052 ext 002 hany.farouk@aswu.edu.eg
Contact: nahla w shady, md 01092440504 ext 002 nahla.elsayed@aswu.edu.eg

Locations
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Egypt
Aswan University Hospital Recruiting
Aswan, Egypt, 81528
Contact: Hany f Sallam, MD    0122336052 ext 002    hany.farouk@aswu.edu.eg   
Contact: Nahla W Shady, MD    01092440504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03880604     History of Changes
Other Study ID Numbers: aswu/207/19
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:
Haemostatic tourniquets
tranexamic acid
myomectomy

Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants