RECRUITING

Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2020-06-20
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04311073

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Undergoing laparoscopic myomectomy
  2. * At least one fibroid greater than or equal to 6 cm
  3. * Any intramural or broad ligament fibroid greater than or equal to 4 cm
  4. * At least 3 total fibroids based on preoperative imaging
  1. * Severe existing medical complications involving the heart, liver, or kidney
  2. * Moderate to severe renal impairment (serum creatinine \> 1.4)
  3. * Blood clotting abnormalities
  4. * Known Allergies to tranexamic acid
  5. * Known Contraindications to Minimally invasive myomectomies
  6. * If you are pregnant
  7. * History of a prior blood clot in the lung arm or leg, known as pulmonary embolism or deep vein thrombosis
  8. * Any active blood clots, clotting disease, pulmonary embolism, cerebral thrombosis, estrogen use, renal impairment, elevated creatinine level
  9. * History of a stroke or mini-strokes
  10. * Concurrent oral contraceptive use
  11. * Contraindications to receiving Tranexamic acid
  12. * In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity
  13. * In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients.
  14. * In patients with active intravascular clotting.
  15. * In patients with hypersensitivity to tranexamic acid or any of the ingredients

Contacts and Locations

Study Contact

Seifeldin Sadek, MD
CONTACT
7574467100
sadeks@evms.edu
Traci Ito, MD
CONTACT
7574467900
itoTE@evms.edu

Principal Investigator

Seifeldin Sadek, MD
PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School

Study Locations (Sites)

EasternVMC
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Eastern Virginia Medical School

  • Seifeldin Sadek, MD, PRINCIPAL_INVESTIGATOR, Eastern Virginia Medical School

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 Registration Dates

Study Start Date2020-06-20
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-06-20
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Tranexamic acid
  • Minimally Invasive
  • Myomectomy
  • Fibroid

Additional Relevant MeSH Terms

  • Fibroid Uterus
  • Abnormal Uterine Bleeding
  • Myoma;Uterus