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Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

Primary Purpose

Pituitary Tumor, Blood Loss, Surgery

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pituitary Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Undergoing endoscopic pituitary surgery at UNC

Exclusion Criteria:

  • Clival invasion
  • Giant pituitary tumor (>4 cm)
  • Revision pituitary surgery
  • Prior sinus surgery
  • Lund McKay score > 3
  • Active thromboembolic disease
  • Coagulopathy
  • Concomitant pro-thrombotic medications
  • Concomitant use of anti-coagulants or anti-platelet agents
  • Subarachnoid hemorrhage
  • History of severe hypersensitivity to Tranexamic Acid

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tranexamic Acid

    Placebo

    Arm Description

    Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.

    Patients in the placebo arm will receive a saline placebo.

    Outcomes

    Primary Outcome Measures

    Mean Blood Loss
    Blood loss measured in mL

    Secondary Outcome Measures

    Intra-operative Surgical Visibility - Wormald Scale Score
    Wormald scale (0-10): The Wormald grading scale is a validated grading tool to measure visual field quality during endoscopic endonasal procedures. Lower scores indicate less bleeding and better surgical visibility. 0 = No bleeding (optimal) = 1-2 points of blood ooze = 3-4 points of ooze = 5-6 points of ooze = 7-8 points of ooze = 9-10 points of ooze = >10 points of ooze, obscuring field = Mild field bleeding with slow post-nasal accumulation = Moderate field bleeding with moderate post-nasal accumulation = Moderate-severe field bleeding with rapid post-nasal accumulation = Severe bleeding (worst) with nose filling rapidly These measurements will take place 6 times. During hours 1, 2, 3, and 4 of the surgery, as well as during sphenoidotomy and durotomy.

    Full Information

    First Posted
    April 23, 2021
    Last Updated
    March 25, 2022
    Sponsor
    University of North Carolina, Chapel Hill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04863339
    Brief Title
    Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery
    Official Title
    Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Challenges in recruitment
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of North Carolina, Chapel Hill

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    This trial is to determine the effect of Tranexamic Acid (TXA) on blood loss during endoscopic pituitary surgery. The hypothesis of this study is that TXA will reduce blood loss during surgery compared to a placebo. To answer this hypothesis, the investigators are conducting a randomized controlled trial in which half of participants will receive TXA and half will receive placebo (saline) in a double blind fashion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pituitary Tumor, Blood Loss, Surgery

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants randomized to receive the investigational product vs placebo during a single study encounter.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The only staff with access to randomization codes will be our study statistician who created the randomization table and our investigational drug services pharmacy who is preparing the investigational product.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic Acid
    Arm Type
    Experimental
    Arm Description
    Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in the placebo arm will receive a saline placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Intervention Description
    Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.
    Primary Outcome Measure Information:
    Title
    Mean Blood Loss
    Description
    Blood loss measured in mL
    Time Frame
    Time between incision and surgical closure, an average of 3 to 3.5 hours
    Secondary Outcome Measure Information:
    Title
    Intra-operative Surgical Visibility - Wormald Scale Score
    Description
    Wormald scale (0-10): The Wormald grading scale is a validated grading tool to measure visual field quality during endoscopic endonasal procedures. Lower scores indicate less bleeding and better surgical visibility. 0 = No bleeding (optimal) = 1-2 points of blood ooze = 3-4 points of ooze = 5-6 points of ooze = 7-8 points of ooze = 9-10 points of ooze = >10 points of ooze, obscuring field = Mild field bleeding with slow post-nasal accumulation = Moderate field bleeding with moderate post-nasal accumulation = Moderate-severe field bleeding with rapid post-nasal accumulation = Severe bleeding (worst) with nose filling rapidly These measurements will take place 6 times. During hours 1, 2, 3, and 4 of the surgery, as well as during sphenoidotomy and durotomy.
    Time Frame
    Duration of operation, up to 4 hours
    Other Pre-specified Outcome Measures:
    Title
    Incidence of Venous Thromboembolism
    Description
    Absolute number of incident venous thromboembolism
    Time Frame
    from time of intervention administration through 1 week after surgery
    Title
    Mean Duration of Surgery
    Description
    Measured in hours
    Time Frame
    Time between incision and surgical closure, an average of 3 to 3.5 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Undergoing endoscopic pituitary surgery at UNC Exclusion Criteria: Clival invasion Giant pituitary tumor (>4 cm) Revision pituitary surgery Prior sinus surgery Lund McKay score > 3 Active thromboembolic disease Coagulopathy Concomitant pro-thrombotic medications Concomitant use of anti-coagulants or anti-platelet agents Subarachnoid hemorrhage History of severe hypersensitivity to Tranexamic Acid
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brent Senior, MD
    Organizational Affiliation
    UNC Chapel Hill
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
    IPD Sharing Time Frame
    12 to 24 months following publication
    IPD Sharing Access Criteria
    Requests for IPD can be made by email and will be reviewed by the PI. The study protocol and deidentified data can be provided for scientific analyses performed by physicians and researchers affiliated with academic institutions.
    Citations:
    PubMed Identifier
    23477634
    Citation
    Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
    Results Reference
    background
    PubMed Identifier
    31008946
    Citation
    Ping WD, Zhao QM, Sun HF, Lu HS, Li F. Role of tranexamic acid in nasal surgery: A systemic review and meta-analysis of randomized control trial. Medicine (Baltimore). 2019 Apr;98(16):e15202. doi: 10.1097/MD.0000000000015202.
    Results Reference
    background
    PubMed Identifier
    32224739
    Citation
    Heyns M, Knight P, Steve AK, Yeung JK. A Single Preoperative Dose of Tranexamic Acid Reduces Perioperative Blood Loss: A Meta-analysis. Ann Surg. 2021 Jan 1;273(1):75-81. doi: 10.1097/SLA.0000000000003793.
    Results Reference
    background
    PubMed Identifier
    25133491
    Citation
    Jahanshahi J, Hashemian F, Pazira S, Bakhshaei MH, Farahani F, Abasi R, Poorolajal J. Effect of topical tranexamic acid on bleeding and quality of surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a triple blind randomized clinical trial. PLoS One. 2014 Aug 18;9(8):e104477. doi: 10.1371/journal.pone.0104477. eCollection 2014.
    Results Reference
    background
    PubMed Identifier
    26554461
    Citation
    Mebel D, Akagami R, Flexman AM. Use of Tranexamic Acid Is Associated with Reduced Blood Product Transfusion in Complex Skull Base Neurosurgical Procedures: A Retrospective Cohort Study. Anesth Analg. 2016 Feb;122(2):503-8. doi: 10.1213/ANE.0000000000001065.
    Results Reference
    background

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