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

NCT04951128 | Unknown Phase 4 FDA Drug

• 1 other identifier: Tranexamic Acid
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Edema; Ecchymosis; Eyelid

Keywords

Tranexamic acid; Post-operative ecchymosis; Post-operative edema

Outcome Measures

Primary Outcomes (2)

• Post-operative edema/ecchymosis

  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

  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 Outcomes (2)

• Post-operative complications

  1st post op visit: post-op day 1 to 3

• Post-operative complications

  2nd post op visit: post-op day 7 to 10

Study Arms (2)

Tranexamic acid arm

EXPERIMENTAL

Eyelid(s) that received tranexamic acid in the local anesthetic

Drug: Tranexamic acid injection

Control

ACTIVE COMPARATOR

Eyelid(s) that receive local anesthetic without tranexamic acid

Other: Local anesthetic control

Interventions

Tranexamic acid injection DRUG

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).

Tranexamic acid arm

Local anesthetic control OTHER

Local anesthetic mixture without tranexamic acid consisting of 2% lidocaine with epinephrine (2.5 mL) and 0.5% bupivacaine with epinephrine (2.5 mL).

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consultants in Ophthalmic and Facial Plastics Surgery: lead

Study Sites (4)

Consultants in Ophthalmic and Facial Plastic Surgery

Southfield, Michigan, 48067, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Houston Methodist

Houston, Texas, 70030, United States

Location

University of Texas - Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Edema; Ecchymosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Thai Do, MD

CONTACT

248-357-5100; tdo@facialworks.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants in this study will undergo bilateral upper/lower eyelid surgery. The treatment side with tranexamic acid will be randomized for each patient using a random coin flip generator (head for the right side and tail for left side). The surgeons, participants, and photo reviewers will be blinded to the treatment side.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 6, 2021
• Study Start: August 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: July 1, 2022
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)