A Phase 1 interventional study of Tranexamic Acid and Saline Solution in Hemorrhage/Blood Loss During Myomectomies and Fibroids, sponsored by George Washington University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by George Washington University · Phase 1, Interventional, and Treatment
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.
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.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
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Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
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Exclusion Criteria:
Concurrent use of:
This arm will receive an injection of Tranexamic Acid
Drug: Tranexamic Acid
This arm will receive an injection of Saline Solution
Other: Saline Solution
Blood Loss
the volume of blood loss will be measured at end of surgery.
Time frame: At time of Surgery
change in pre-operative and immediately post-operative hemoglobin
Time frame: At time of Surgery
frequency of blood transfusions
Time frame: At time of Surgery
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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