Recruiting

Tranexamic Acid

Sponsor:

Montefiore Medical Center

Code:

NCT06450392

Conditions

Orbital Edema

Orbital Ecchymosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic acid injection

Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)

normal saline - injection

normal saline - intravenous

Study Details

Brief summary:

Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions, traumatic hemorrhage, cardiac surgery, total knee arthroplasty, and more, there is a paucity of clinical data on TXA use in plastic surgery. The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital surgery.

Conditions

Orbital Edema

Orbital Ecchymosis

Study ID

NCT06450392

Start date

Oct 7, 2024

Status verified date

Dec, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
  • Patients who are at least 18 years of age
  • Patients that have the capacity to consent

Exclusion Criteria:

  • Any history of previous orbital surgery
  • Any patient undergoing multiple simultaneous periocular surgical procedures
  • Any patient with active infection
  • History of stroke or seizure
  • History of bleeding/clotting disorder
  • Patients who do not comply with the required postoperative follow-up schedule
  • Patients who are allergic to tranexamic acid
  • Patients who have taken anticoagulant/antiplatelet agents (including aspirin) within 7 days prior to surgery
  • Patients who have periocular ecchymosis or edema prior to surgery

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Group 1: IV TXA

1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery

experimental: Group 2: Local TXA

1-2mL of subcutaneous tranexamic acid 100 mg/mL (manufactured concentration, Pfizer, New York, NY) mixed with local anesthetic to the orbit two minutes prior to incision

placebo comparator: Group 3: Control

Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group

Interventions

Tranexamic acid injection

100 mg/mL (manufactured concentration) local TXA injection in the orbit

Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)

1g IV TXA

normal saline - injection

0.9% Normal Saline injection in the orbit

normal saline - intravenous

0.9% IV Normal Saline

Primary outcome measure

  • Degree of Ecchymosis [ Time Frame: 0 days and 7 days postoperatively ]
  • Degree of Edema [ Time Frame: 0 days and 7 days postoperatively ]

Central Contacts and Locations

Central contacts

Anne Barmettler

718-920-4609abarmett@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Anne Barmettler, MD

718-920-4609abarmett@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Orbital Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2025-12-16.