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The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Primary Purpose

Eyelid Diseases, Periorbital Disorder, Hemorrhage

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Eyelid Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR). Exclusion Criteria: - Adults unable to consent Individuals less than 18 years of age Prisoners Pregnant women. Known contradictions or sensitivities to study medication (tranexamic acid) Patients with known prior thromboembolic events Previous eyelid surgery or same-side DCR (RE-DCR) Has any type of coagulopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tranexamic Acid Group

    Placebo Group

    Arm Description

    Participants undergoing standard of care periorbital procedures will be randomized to receive tranexamic acid with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.

    Participants undergoing standard of care periorbital procedures will be randomized to receive balanced salt solution with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.

    Outcomes

    Primary Outcome Measures

    Postoperative patient ecchymosis
    Ecchymosis will be graded 0-3 based on location and degree based on a previously reported validated scale (higher scores with more ecchymosis)

    Secondary Outcome Measures

    Postoperative patient chemosis
    Chemosis, swelling of the eyes, will be measured on a scale of 0-4 (higher scores, more edema)
    Eyelid edema
    Measurement includes through Surgeon Periorbital Ration of Edema and Ecchymosis (SPREE), which has a total score ranging from 1 to 4 with the higher score indicating more severe eyelid edema.
    Intraoperative patient bleeding
    The amount of blood loss intraoperatively will be measured using a scale for blood soaked materials.
    Physician Perception of Intraoperative Bleeding
    The primary surgeon will subjectively rank the efficacy of hemostasis on a scale of 1-4 [excellent (1), good (2), moderate (3), or poor (4) ] immediately after the operation.
    Patient-perceived outcomes
    Patients will complete a validated FACE-Q survey which has a raw score converted to a scaled score of from 0-100, with higher scores indicating a better outcome.

    Full Information

    First Posted
    December 21, 2022
    Last Updated
    September 15, 2023
    Sponsor
    University of Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05672407
    Brief Title
    The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
    Official Title
    The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Research team dissembled because of no funding.
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2026 (Anticipated)
    Study Completion Date
    June 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    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.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eyelid Diseases, Periorbital Disorder, Hemorrhage, Surgical Blood Loss

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic Acid Group
    Arm Type
    Experimental
    Arm Description
    Participants undergoing standard of care periorbital procedures will be randomized to receive tranexamic acid with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants undergoing standard of care periorbital procedures will be randomized to receive balanced salt solution with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Intervention Description
    100 mg/mL Tranexamic acid with lidocaine with 1:100,000 epinephrine in 1:1 manner administered subcutaneously
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Balanced Saline Solution
    Intervention Description
    Lidocaine with 1:100,000 epinephrine mixed with 1:1 Basal Saline Solution (BSS) administered subcutaneously
    Primary Outcome Measure Information:
    Title
    Postoperative patient ecchymosis
    Description
    Ecchymosis will be graded 0-3 based on location and degree based on a previously reported validated scale (higher scores with more ecchymosis)
    Time Frame
    Up to 3 months
    Secondary Outcome Measure Information:
    Title
    Postoperative patient chemosis
    Description
    Chemosis, swelling of the eyes, will be measured on a scale of 0-4 (higher scores, more edema)
    Time Frame
    Up to 3 months
    Title
    Eyelid edema
    Description
    Measurement includes through Surgeon Periorbital Ration of Edema and Ecchymosis (SPREE), which has a total score ranging from 1 to 4 with the higher score indicating more severe eyelid edema.
    Time Frame
    Up to 3 months
    Title
    Intraoperative patient bleeding
    Description
    The amount of blood loss intraoperatively will be measured using a scale for blood soaked materials.
    Time Frame
    Postoperative day 0 (day of surgery)
    Title
    Physician Perception of Intraoperative Bleeding
    Description
    The primary surgeon will subjectively rank the efficacy of hemostasis on a scale of 1-4 [excellent (1), good (2), moderate (3), or poor (4) ] immediately after the operation.
    Time Frame
    Postoperative day 0 (day of surgery)
    Title
    Patient-perceived outcomes
    Description
    Patients will complete a validated FACE-Q survey which has a raw score converted to a scaled score of from 0-100, with higher scores indicating a better outcome.
    Time Frame
    Up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR). Exclusion Criteria: - Adults unable to consent Individuals less than 18 years of age Prisoners Pregnant women. Known contradictions or sensitivities to study medication (tranexamic acid) Patients with known prior thromboembolic events Previous eyelid surgery or same-side DCR (RE-DCR) Has any type of coagulopathy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wendy W Lee, MD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

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