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Search / Trial NCT02620748

Use of Intravenous Tranexamic Acid During Myomectomy

Launched by GEORGE WASHINGTON UNIVERSITY · Dec 2, 2015

Trial Information

Current as of July 04, 2025

Completed

Keywords

ClinConnect Summary

Worldwide about 25% of women will develop uterine leiomyomas. Most myomas are asymptomatic however 20 to 25% of women with myomas develop symptoms, such as heavy menstrual bleeding, requiring treatment. For women failing medical management and desiring to preserve fertility and/or their uterus, surgical removal of fibroids (myomectomy) is the major option. Myomectomy is associated with both short and long-term complications, most significantly, hemorrhage and need for conversion to hysterectomy in 2% of cases, need for a blood transfusion in up to 20% of cases, prolonged postoperative stay,...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • women undergoing laparoscopic, robotic or abdominal myomectomy
  • fibroid burden meeting the following criteria based on ultrasound imaging: Fibroids greater than or equal to 10 cm Intramural or Broad Ligament Fibroid greater than or equal to 6 cm Number of fibroids greater than or equal to 5 cm
  • Exclusion Criteria:
  • Medical history of the following: thromboembolic disease, ischemic heart disease, malignancy, hematuria, liver disease, chronic kidney disease or subarachnoid hemorrhage
  • pregnant women
  • women who are nursing
  • women with active thrombotic or thromboembolic disease
  • women with history of intrinsic risk of thrombosis or thromboembolism
  • hypersensitivity to Tranexamic Acid
  • Concurrent use of:
  • combination of hormonal contraception
  • factor IX complex concentrates
  • Anti-inhibitor coagulant concentrates
  • all-trans retinoic acid

About George Washington University

George Washington University (GWU) is a leading academic institution dedicated to advancing medical research and education. As a clinical trial sponsor, GWU leverages its extensive resources and expertise to facilitate innovative studies that aim to improve healthcare outcomes. The university's commitment to ethical research practices, collaboration with multidisciplinary teams, and engagement with diverse populations underscores its role in addressing critical health challenges. By fostering a rigorous scientific environment, GWU strives to translate research findings into effective clinical applications, ultimately enhancing patient care and contributing to the broader medical community.

Locations

Washington, District Of Columbia, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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