Use of Intravenous Tranexamic Acid During Myomectomy

• Status: Completed
• Trial end date: 2018-02-22
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cherie Q. Marfori; George Washington University
• Treatments: Tranexamic Acid

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