Recruiting
Phase 3

Tranexamic Acid

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT03216083

Conditions

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid Injectable Solution

Placebo

Study Details

Brief 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.

Conditions

Pelvic Organ Prolapse

Study ID

NCT03216083

Start date

Jan 1, 2018

Status verified date

Apr, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • female patients over the age of 18
  • undergoing a vaginectomy by a member of the Urogynaecology department, with or without concomitant anti-incontinence mid-urethral sling

Exclusion Criteria:

  • concomitant hysterectomy at the time of vaginectomy
  • inability to read and speak English if no family member or interpreter available for consent process
  • cognitively impaired and unable to personally sign consent
  • known allergy or intolerance to TXA
  • previous venous thromboembolic event
  • significant renal impairment (creatinine greater than 200micromol/L or creatinine clearance less than 50mL/min)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Tranexamic Acid

Tranexamic Acid Injectable Solution (1g intravenous) Single dose prior to the start of surgery, after the induction of anesthesia

placebo comparator: Placebo

67mL intravenous normal saline (0.9% sodium chloride) Single dose prior to the start of surgery, after the induction of anesthesia

Interventions

Tranexamic Acid Injectable Solution

1g IV tranexamic acid mixed in normal saline (67mL)

Placebo

67mL IV normal saline

Primary outcome measure

  • Change in hemoglobin [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

Contacts

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Apr 6, 2022

Last verified

Apr, 2022

Keywords

  • colpocleisis
  • vaginectomy
  • tranexamic acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2022-04-06.