Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

September 7, 2023 updated by: Eastern Virginia Medical School

Randomized Control Trial Investigating for Prophylactic Tranexamic Acid Use at Time of Minimally Invasive Myomectomies

This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision.

Study Overview

Detailed Description

This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. These subjects will be then approached for consent during their pre-op visit 1-2 weeks prior to their surgery. The setting for consent will be in a patient consultation room. A total of 50 women in each arm of the study with symptomatic fibroids meeting any of the following criteria will be included in the study:

  1. At least one fibroid greater than or equal to 6 cm
  2. Any intramural or broad ligament fibroid greater than or equal to 4 cm
  3. At least 3 total fibroids based on preoperative imaging. Randomization will be performed using an automated randomization website Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision. This dosage will not be adjusted for patients with renal insufficiency as they will be excluded from the study. Preparation of the medications will be performed by anesthesia who have both medication and normal saline available to them on short notice. No prior preparation by pharmacy will be required. Tranexamic acid is readily available in a 10 ml vial, which does not need a pharmacist to prepare for administration. The vial is mixed with 50 ml of saline in the operating room. This is the same process that occurs outside of any study with any medication that is administered intra-operatively. This will in no way impact the patient's safety during the surgery, especially since it is administered 15 minutes prior to the start of the procedure.

Both surgeon and patient will be blinded to the treatment arm. This dosage has been used previously in both obstetric and gynecological procedures and is the same dose recommended by the WHO for preventing post-partum hemorrhage The surgery itself will be scheduled at either Sentara Norfolk General, Sentara Leigh hospital, and Sentara Princess Anne hospital. These are the three sites that the investigators already perform Minimally invasive myomectomies.

An envelope will be given to the anesthesiologist prior to the procedure informing whether they are to receives TXA or the placebo. Blood loss will be estimated by the surgeon performing the procedure. Hemoglobin and hematocrit will be obtained 24 hours post procedure. The patient will be assessed for reported side effects from the medication given will be assessed by a questionnaire that will be given at their post-op appointment at the 2 week and 6-week mark. During these two visits a physical exam is performed, checking incision sites, and patient symptoms, all of which are standard of care for any minimally invasive procedure. The patients will be seen at the EVMS outpatient clinic for Gynecology, or depending with the physician who performed the surgery. Data will be collected from both Allscripts and EPIC charts.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seifeldin Sadek, MD
  • Phone Number: 7574467100
  • Email: sadeks@evms.edu

Study Contact Backup

Study Locations

    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • EasternVMC
        • Contact:
        • Contact:

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Undergoing laparoscopic myomectomy
  • At least one fibroid greater than or equal to 6 cm
  • Any intramural or broad ligament fibroid greater than or equal to 4 cm
  • At least 3 total fibroids based on preoperative imaging

Exclusion Criteria:

  • Severe existing medical complications involving the heart, liver, or kidney
  • Moderate to severe renal impairment (serum creatinine > 1.4)
  • Blood clotting abnormalities
  • Known Allergies to tranexamic acid
  • Known Contraindications to Minimally invasive myomectomies
  • If you are pregnant
  • History of a prior blood clot in the lung arm or leg, known as pulmonary embolism or deep vein thrombosis
  • Any active blood clots, clotting disease, pulmonary embolism, cerebral thrombosis, estrogen use, renal impairment, elevated creatinine level
  • History of a stroke or mini-strokes
  • Concurrent oral contraceptive use
  • Contraindications to receiving Tranexamic acid
  • In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity
  • In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients.
  • In patients with active intravascular clotting.
  • In patients with hypersensitivity to tranexamic acid or any of the ingredients

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic Acid
Patients will receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline 15 minutes prior to initial surgical incision time
IV Tranexamic acid in 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.
Placebo Comparator: Placebo
Patients will receive an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision
IV normal saline 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated blood loss
Time Frame: Duration of procedure up to 420 minutes
Estimated blood loss at time of procedure completion; using volume of cannister and weight of lap sponges
Duration of procedure up to 420 minutes
Calculated blood loss
Time Frame: From post operative day 0 until postoperative day 1
Calculated Blood loss, using pre-operative hematocrit, postoperative hematocrit and estimated blood volume x Body Mass Index
From post operative day 0 until postoperative day 1
Number of blood products received
Time Frame: Duration of hospital stay up to two days
Number of blood products received during admission that is directly due to blood loss at time of procedure
Duration of hospital stay up to two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: Duration of surgery up to 420 minutes
Start time of procedure until end time of procedure
Duration of surgery up to 420 minutes
Length of hospital stay
Time Frame: Duration of stay in hospital, up to two days
Recorded in days
Duration of stay in hospital, up to two days
Number of fibroids removed
Time Frame: Duration of surgery, up to 420 minutes
Total number of fibroids removed during procedure
Duration of surgery, up to 420 minutes
Fibroid type
Time Frame: through completion of study average 8 weeks
type of fibroid per FIGO classification
through completion of study average 8 weeks
Weight of fibroids removed
Time Frame: duration of surgery up to 420 minutes
total weight of fibroids removed
duration of surgery up to 420 minutes
Pain index
Time Frame: duration of hospital stay, up to two days
Pain index score on postoperative day 1 and 14 Score of 0-10 0 = no pain, 10 = significant amount of pain
duration of hospital stay, up to two days
Incidence of postoperative complication
Time Frame: Duration of hospital stay , up to two days

Immediate postoperative complication:

Hemorrhage Infection Fever Deep vein thrombosis Hysterectomy Re-exploration Hospital readmission

Duration of hospital stay , up to two days
Questionnaire for incidence of mild side effect of medication
Time Frame: only on postoperative day 1 , one day
Reported mild effective of medication of post operative day 1
only on postoperative day 1 , one day
Questionnaire for incidence of serious side effect of medication
Time Frame: Only on postoperative day 1, one day
Reported serious side effect of medication on post operative day 1
Only on postoperative day 1, one day
tPA receptor
Time Frame: From time of randomization until postoperative visit, four weeks
Percentage of tPA receptor located in fibroid and myometrium
From time of randomization until postoperative visit, four weeks
PAI-1 receptor
Time Frame: From time of randomization until postoeprative visit, four weeks
Percentage of PAI-1receptor located in fibroid and myometrium
From time of randomization until postoeprative visit, four weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Seifeldin Sadek, MD, Eastern Virginia Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 20, 2020

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

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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