The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery

Description

Tranexamic acid 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 Overview

Study Details

Study overview

Tranexamic acid 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.

The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial

The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery

Condition
Orbital Edema
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10466

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Montefiore Medical Center,

Anne Barmettler, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center/Albert Einstein College of Medicine

Study Record Dates

2027-01