Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?
Primary Purpose
Pelvic Organ Prolapse
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tranexamic Acid Injectable Solution
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pelvic Organ Prolapse focused on measuring colpocleisis, vaginectomy, tranexamic acid
Eligibility Criteria
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)
Sites / Locations
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tranexamic Acid
Placebo
Arm Description
Tranexamic Acid Injectable Solution (1g intravenous) Single dose prior to the start of surgery, after the induction of anesthesia
67mL intravenous normal saline (0.9% sodium chloride) Single dose prior to the start of surgery, after the induction of anesthesia
Outcomes
Primary Outcome Measures
Change in hemoglobin
From pre-operative to the morning after surgery
Secondary Outcome Measures
Blood loss
estimated by surgical team (looking at suction and sponges)
Change in hematocrit
From pre-operative to the morning after surgery
Full Information
NCT ID
NCT03216083
First Posted
July 10, 2017
Last Updated
April 4, 2022
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT03216083
Brief Title
Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?
Official Title
Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy? A Double-blind, Placebo-controlled, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
There are many risks for patients undergoing surgery, with blood loss and the risk of resulting anemia and blood transfusion being a common one. Surgeons are constantly working to reduce patient morbidity by decreasing blood loss during procedures. This can be done via excellent surgical technique and meticulous hemostasis but the addition of medications can also be a valuable tool in reducing the amount of blood loss.
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.
In gynecology, oral TXA has been used for years in the management of menorrhagia and has been shown to be very effective at decreasing blood loss. In other areas of medicine the IV formulation has shown to reduce death due to bleeding in trauma patients as well as in women experiencing post-partum hemorrhage. Recent RCTs on its use in benign hysterectomy, as well as in advanced ovarian cancer surgery have shown a decrease in blood loss of more than 25% without an increase in adverse events, specifically venous thromboembolic events.
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.
Blood loss with a vaginectomy can vary but is not insignificant, especially in elderly women who may have cardiac compromise or pre-existing anemia. The average blood loss quoted in the literature for total colpocleisis varies from 135mL to 396mL, depending on the study. This gives an overall average of about 225mL. If the average patient has a blood volume of 4550mL (calculated based on 65mL/kg in women with a weight of 70kg) this represents a decrease of approximately 5%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
colpocleisis, vaginectomy, tranexamic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Tranexamic Acid Injectable Solution (1g intravenous) Single dose prior to the start of surgery, after the induction of anesthesia
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
67mL intravenous normal saline (0.9% sodium chloride) Single dose prior to the start of surgery, after the induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid Injectable Solution
Other Intervention Name(s)
Cyklokapron
Intervention Description
1g IV tranexamic acid mixed in normal saline (67mL)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
67mL IV normal saline
Primary Outcome Measure Information:
Title
Change in hemoglobin
Description
From pre-operative to the morning after surgery
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Blood loss
Description
estimated by surgical team (looking at suction and sponges)
Time Frame
2 hours
Title
Change in hematocrit
Description
From pre-operative to the morning after surgery
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen McDermott, MD
Phone
416-586-4800
Ext
6490
Email
Colleen.McDermott@sinaihealthsystem.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen McDermott, MD
Organizational Affiliation
Mount Sinai Hospital - University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen D McDermott, MD
Phone
516-586-4800
Ext
6490
Email
colleen.mcdermott@utoronto.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?
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