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Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy?

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ClinicalTrials.gov Identifier: NCT03216083
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Drug: Tranexamic Acid Injectable Solution Other: Placebo Phase 3

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%.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Intravenous Tranexamic Acid Reduce Blood Loss During Vaginectomy? A Double-blind, Placebo-controlled, Randomized Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid
Tranexamic Acid Injectable Solution (1g intravenous) Single dose prior to the start of surgery, after the induction of anesthesia
Drug: Tranexamic Acid Injectable Solution
1g IV tranexamic acid mixed in normal saline (67mL)
Other Name: Cyklokapron

Placebo Comparator: Placebo
67mL intravenous normal saline (0.9% sodium chloride) Single dose prior to the start of surgery, after the induction of anesthesia
Other: Placebo
67mL IV normal saline
Other Name: Normal saline




Primary Outcome Measures :
  1. Change in hemoglobin [ Time Frame: 4 weeks ]
    From pre-operative to the morning after surgery


Secondary Outcome Measures :
  1. Blood loss [ Time Frame: 2 hours ]
    estimated by surgical team (looking at suction and sponges)

  2. Change in hematocrit [ Time Frame: 4 weeks ]
    From pre-operative to the morning after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216083


Contacts
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Contact: Colleen McDermott, MD 416-586-4800 ext 6490 Colleen.McDermott@sinaihealthsystem.ca

Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Colleen D McDermott, MD    516-586-4800 ext 6490    colleen.mcdermott@utoronto.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Colleen McDermott, MD Mount Sinai Hospital - University of Toronto

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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03216083     History of Changes
Other Study ID Numbers: FPMRS McD 002
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Mount Sinai Hospital, Canada:
colpocleisis
vaginectomy
tranexamic acid
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants