Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?
Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
There are many risks for patients undergoing surgery, with blood loss and the risk of
resulting anemia and blood transfusion being a common one. Decreasing blood loss with
medication can be an important tool in reducing post-operative complications. Tranexamic acid
(TXA) is an anti-fibrinolytic that inhibits the activation of plasminogen to plasmin. It
inhibits the ability of plasminogen to dissolve fibrin networks, thus decreasing bleeding.
TXA was shown in a systematic review and meta-analysis by Ker et. al in 2013 to reduce
surgical blood loss by an average of 34% with an increased percentage reduction as the amount
of bleeding during surgery decreased. This review also showed that a dose of 1g intravenous
(IV) was sufficient in most adults with no evidence supporting a higher dose.
Vaginectomy or total colpocleisis is a surgical procedure performed for women experiencing
symptomatic pelvic organ prolapse. It is performed in women who have significant vaginal
vault prolapse post-hysterectomy and wish an effective treatment but accept the inability of
having penetrative vaginal intercourse. It is most often performed in older patients who have
multiple co-morbidities that would preclude them from having a more invasive procedure to
correct their prolapse, such as an abdominal sacral colpopexy which involves the placement of
surgical mesh, is a significantly longer procedure, and has more associated surgical risks.
This study will be a double-blind, placebo-controlled, randomized trial looking at whether 1g
IV tranexamic acid compared with placebo reduces blood loss in women undergoing vaginectomy.