Use of Intravenous Tranexamic Acid During Myomectomy
Condition: Hemorrhage/Blood Loss During Myomectomies; Fibroids
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Tranexamic Acid; Saline Solution
Intervention type(s): Drug; Other
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment