Use of Tranexamic Acid in Blepharoplasties

NCT04724772 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: STU00211373
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this investigation is to assess whether or not there is a significant difference in the presence and/or degree of post-operative ecchymosis, pain, and edema between groups of patients undergoing upper lid blepharoplasty with traditional local anesthetic (LA) and those who receive tranexamic acid (TXA) in addition to traditional LA.

Conditions

Pain, Postoperative; Bruising

Outcome Measures

Primary Outcomes (2)

• change in bruising

  patients are given a survey to rate bruising on each side, change will be assessed from different time periods

  Surveys will be completed by patients at 1 week, 1 month, 3 months post-operatively

• change in bruising a survey to rate pain

  patients are given a survey to rate pain on each side, change will be assessed from different time periods

  Surveys will be completed by patients at 1 week, 1 month, 3 months post-operatively

Study Arms (1)

Blepharoplasty patient

EXPERIMENTAL

Patient receives LA in one eye and LA with TXA in the other eye. They are blinded. They compare eyes without knowing which one received the TXA.

Drug: Tranexamic acid injection

Interventions

Tranexamic acid injection DRUG

Injection of tranexamic acid preoperatively

Blepharoplasty patient

Eligibility Criteria

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

You may qualify if:

• any adult patient who is undergoing upper lid blepharoplasty with author Douglas Sidle, MD and who is older than 18 years of age, fluent in English, not on any anticoagulant or antiplatelet medication (e.g. aspirin, clopidogrel, etc.), not diagnosed with a coagulation disorder, not pregnant, not undergoing a simultaneous procedure, and not a Feinberg School of Medicine (FSM) student or Northwestern Memorial (NM) employee.

You may not qualify if:

• less than 18 years of age, not fluent in English, taking anticoagulant or antiplatelet, has coagulation disorder, pregnant, simultaneous procedure, FSM or NM student/employee

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Contusions

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wounds, Nonpenetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: The patient does not know which side receives the TXA in addition to the LA. They then personally assess pain and bruising. The provider is blinded to which syringe has both TXA and LA, and which only has LA.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Each patient is blinded to which eye receives TXA. All patients have both eyes injected with LA, and one eye injected with TXA.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 26, 2021
• Study Start: February 20, 2020
• Primary Completion: July 20, 2023
• Study Completion: September 20, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)