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Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery

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ClinicalTrials.gov Identifier: NCT04863339
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Pituitary Tumor Blood Loss Surgery Drug: Tranexamic acid Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomized to receive the investigational product vs placebo during a single study encounter.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Other
Official Title: Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery: A Double-Blind Randomized Controlled Trial
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid
Participants in the Tranexamic Acid arm will receive a dose of Tranexamic Acid.
Drug: Tranexamic acid
Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.

Placebo Comparator: Placebo
Patients in the placebo arm will receive a saline placebo.
Drug: Placebo
Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.




Primary Outcome Measures :
  1. Mean Blood Loss [ Time Frame: Time between incision and surgical closure, an average of 3 to 3.5 hours ]
    Blood loss measured in mL


Secondary Outcome Measures :
  1. Intra-operative Surgical Visibility - Wormald Scale Score [ Time Frame: Duration of operation, up to 4 hours ]

    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. = 1-2 points of blood ooze
    2. = 3-4 points of ooze
    3. = 5-6 points of ooze
    4. = 7-8 points of ooze
    5. = 9-10 points of ooze
    6. = >10 points of ooze, obscuring field
    7. = Mild field bleeding with slow post-nasal accumulation
    8. = Moderate field bleeding with moderate post-nasal accumulation
    9. = Moderate-severe field bleeding with rapid post-nasal accumulation
    10. = 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.



Other Outcome Measures:
  1. Incidence of Venous Thromboembolism [ Time Frame: from time of intervention administration through 1 week after surgery ]
    Absolute number of incident venous thromboembolism

  2. Mean Duration of Surgery [ Time Frame: Time between incision and surgical closure, an average of 3 to 3.5 hours ]
    Measured in hours



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT04863339


Contacts
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Contact: Brent Senior, MD 919-966-3344 Brent_Senior@med.unc.edu

Locations
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United States, North Carolina
UNC Chapel Hil Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Brent Senior, MD    919-966-3344    Brent_Senior@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Brent Senior, MD UNC Chapel Hill
Publications:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04863339    
Other Study ID Numbers: 20-2267
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: 12 to 24 months following publication
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.

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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
Additional relevant MeSH terms:
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Pituitary Neoplasms
Central Nervous System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Pituitary Diseases
Hemorrhage
Pathologic Processes
Hypothalamic Diseases
Brain Diseases
Nervous System Diseases
Endocrine System Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants