RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-07
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06450392

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
  2. * Patients who are at least 18 years of age
  3. * Patients that have the capacity to consent
  1. * Any history of previous orbital surgery
  2. * Any patient undergoing multiple simultaneous periocular surgical procedures
  3. * Any patient with active infection
  4. * History of stroke or seizure
  5. * History of bleeding/clotting disorder
  6. * Patients who do not comply with the required postoperative follow-up schedule
  7. * Patients who are allergic to tranexamic acid
  8. * Patients who have taken anticoagulant/antiplatelet agents (including aspirin) within 7 days prior to surgery
  9. * Patients who have periocular ecchymosis or edema prior to surgery

Contacts and Locations

Study Contact

Anne Barmettler
CONTACT
718-920-4609
abarmett@montefiore.org

Principal Investigator

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

Study Locations (Sites)

Montefiore Medical Center
The Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

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

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 Registration Dates

Study Start Date2024-10-07
Study Completion Date2027-01

Study Record Updates

Study Start Date2024-10-07
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Orbital Surgery

Additional Relevant MeSH Terms

  • Orbital Edema
  • Orbital Ecchymosis