Back to resultsThe 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Withdrawn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
About this trial
This is an interventional supportive care trial for Eyelid Diseases
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
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
NCT ID
NCT05672407
First Posted
December 21, 2022
Last Updated
September 15, 2023
Sponsor
University of Miami
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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