The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery

July 1, 2021 updated by: Consultants in Ophthalmic and Facial Plastics Surgery
Tranexamic acid (TXA) is a synthetic inhibitor of plasminogen lysine receptor that has used to reduce intra-operative bleeding in a number of clinical scenarios. Anecdotally, TXA has used by plastic surgeons to reduce post-operative bruising. To date, there is limited data to valid the benefits and to evaluate the side effects of TXA. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reduce bleeding. Recent studies have demonstrated the antifibrinolytic benefits of TXA in a number of clinical scenarios, including heavy menstrual bleeding, traumatic hemorrhage, elective cesarean section, total knee arthroplasty, coronary artery surgery, spinal deformity surgery, orthognathic surgery, transurethral prostate resection, aneurysmal subarachnoid hemorrhage, epistaxis, and hemoptysis.

Anecdotally, TXA has been used by plastic surgeons to reduce postoperative bruising. However, there is a paucity of clinical data on TXA use in plastic surgery, and the results are inconsistent. In a prospective randomized controlled trial evaluating local TXA in upper blepharoplasty, Sagiv et al reported no intraoperative blood loss, surgeon's assessment of hemostasis, and periocular ecchymosis size on postoperative day 1. Butz and Geldner reviewed their experience placing TXA-soaked pledgets in 57 patients who underwent face lift18. They identified only 1 patient who had post-operative hematoma and they reported no systemic complications from TXA use. In a randomized control trial evaluating topical TXA in reduction mammoplasty, Ausen et al reported 39% reduction of postoperative fluid drainage on the treatment side. In a study evaluating oral TXA and cortisone effect in rhinoplasty, Sakalliogu et al reported significant reduction of intraoperative bleeding and postoperative ecchymosis/edema in patients who underwent rhinoplasty. Further study is warranted to evaluate the use to TXA in plastic surgery. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Southfield, Michigan, United States, 48067
        • Consultants in Ophthalmic and Facial Plastic Surgery
        • Contact:
        • Principal Investigator:
          • Dianne Schlachter, MD
        • Sub-Investigator:
          • Evan Black, MD
        • Sub-Investigator:
          • Thai Do, MD
        • Sub-Investigator:
          • Peter Kally, MD
    • New York
      • Bronx, New York, United States, 10467
    • Texas
      • Houston, Texas, United States, 70030
      • Houston, Texas, United States, 77030
        • University of Texas - Health Science Center at Houston
        • Contact:
        • Sub-Investigator:
          • Daniel Jones, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 18 years old
  • Undergo bilateral upper/lower eyelid blepharoplasty, bilateral upper eyelid ptosis repair, or a combination of the above procedures
  • Additional concurrent forehead/brow or upper/lower eyelids surgeries may be included if bilateral

Exclusion Criteria:

  • Prior eyelid surgery
  • Anticoagulant or antiplatelet use, including aspirin, within 7 days prior to surgery
  • Patient who is currently pregnant or breast feeding
  • Patient with color vision deficiency
  • TXA allergy
  • History of bleeding disorder
  • History of clotting disorder
  • History of seizure
  • Have active nausea/vomiting/gastrointestinal symptoms
  • Have active intracranial bleeding
  • Have active periocular ecchymosis or edema prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tranexamic acid arm
Eyelid(s) that received tranexamic acid in the local anesthetic
Drug: Tranexamic acid injection
Tranexamic acid (100 mg/mL concentration; 0.5 mL) will be added to local anesthetic mixture of 2% lidocaine with epinephrine (2.25 mL) and 0.5% bupivacaine with epinephrine (2.25mL).
ACTIVE_COMPARATOR: Control
Eyelid(s) that receive local anesthetic without tranexamic acid
Other: Local anesthetic control
Local anesthetic mixture without tranexamic acid consisting of 2% lidocaine with epinephrine (2.5 mL) and 0.5% bupivacaine with epinephrine (2.5 mL).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative edema/ecchymosis
Time Frame: 1st post op visit: post-op day 1 to 3
Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising)
1st post op visit: post-op day 1 to 3
Post-operative edema/ecchymosis
Time Frame: 2nd post op visit: post-op day 7 to 10
Post-operative edema/ecchymosis will be graded by Winkler-Black Bruising Scale (0= no bruising, 1= mild bruising, 2=moderate bruising, 3=severe bruising)
2nd post op visit: post-op day 7 to 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: 1st post op visit: post-op day 1 to 3
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis
1st post op visit: post-op day 1 to 3
Post-operative complications
Time Frame: 2nd post op visit: post-op day 7 to 10
Potential complications: allergic reaction, persistent bleeding, thromboembolic event, wound dehiscence, wound infection, or tissue necrosis
2nd post op visit: post-op day 7 to 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consultants in Ophthalmic and Facial Plastics Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

July 1, 2022

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (ACTUAL)

July 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tranexamic Acid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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