Use of Intravenous Tranexamic Acid During Myomectomy

Completed · Phase 1

Conditions studied: Hemorrhage/Blood Loss During Myomectomies, Fibroids

In brief

The purpose of this study is to determine the effect of the early administration of intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb), and frequency of blood transfusions) in women undergoing a myomectomy.

Key facts

Study ID

NCT02620748

Run by

George Washington University

People needed

60

Starts

2015-03-01

Expected to finish

2018-02-22

Last updated by the study team

2022-10-13

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical Faculty Associates — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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