Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?

NCT03216083 | Unknown Phase 3

• 1 other identifier: FPMRS McD 002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

colpocleisis; vaginectomy; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin

  From pre-operative to the morning after surgery

  4 weeks

Secondary Outcomes (2)

• Blood loss

  2 hours

• Change in hematocrit

  4 weeks

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

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

Drug: Tranexamic Acid Injectable Solution

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Tranexamic Acid Injectable Solution DRUG

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

Also known as: Cyklokapron

Tranexamic Acid

Placebo OTHER

67mL IV normal saline

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Colleen McDermott, MD

  Mount Sinai Hospital - University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen McDermott, MD

CONTACT

416-586-4800; Colleen.McDermott@sinaihealthsystem.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: January 1, 2018
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)