Use of Intravenous Tranexamic Acid During Myomectomy

NCT ID: NCT02620748

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-02-22

Brief 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.

Detailed Description

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, and can be potentially life-threatening. As such, various treatments have been suggested to decrease blood loss during myomectomy including pharmacologic manipulation of the coagulation cascade using agents such as tranexamic acid (TA). Despite the many described methods to reduce intraoperative bleeding, massive hemorrhage during myomectomy remains a significant challenge to gynecologic surgeons.

TA is a synthetic lysine derivative with antifibrinolytic activity that helps prevent clot break down. It is currently clinically used widely to stop heavy menstrual bleeding and many of the investigators' myomectomy patients are taking oral TA around the time of surgery. Systematic reviews of randomized control trials (RCTs) including over 25,000 patients of tranexamic acid in elective surgery showed that it reduced the risk of a blood transfusion by 34% (relative risk (RR) 0.61, 95% confidence interval (CI) 0.53 to 0.70) without an increased risk in venous thrombus embolus (VTE) or other adverse perioperative outcomes (Henry, 2011). Only one RCT has studied the use of TA during gynecologic surgery. This study was a randomized double blind placebo controlled trial of intravenous TA 10 mg/kg (maximum 1g) versus placebo during myomectomy procedures. Although there was a 63 ml decrease in postoperative blood loss (p<0.01), no significant difference was found between the two groups in terms of perioperative blood loss, change in hemoglobin, or rate of allogeneic blood transfusions. Further studies are needed with different dosing administration to confirm the true role of TA in the reduction of blood loss during myomectomy.

If a difference is seen, the results of future publications would directly impact clinical care locally and abroad, as few methods currently exist to prevent hemorrhage during myomectomy procedures.

Conditions

Hemorrhage/Blood Loss During Myomectomies; Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tranexamic Acid

This arm will receive an injection of Tranexamic Acid

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Saline

This arm will receive an injection of Saline Solution

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: OTHER

Interventions

Tranexamic Acid

Intervention Type: DRUG

Saline Solution

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Faculty Associates

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

091454

Identifier Type: -

Identifier Source: org_study_id