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Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

NCT04311073 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-09-11

No results posted yet for this study

Summary

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.

Conditions

  • Fibroid Uterus
  • Abnormal Uterine Bleeding
  • Myoma;Uterus

Interventions

DRUG

Tranexamic Acid

IV Tranexamic acid in 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

DRUG

Placebos

IV normal saline 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

Sponsors & Collaborators

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Seifeldin Sadek, MD · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2024-07-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311073 on ClinicalTrials.gov