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RecruitingPhase 4NCT06450392

The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis 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

Sponsor

Montefiore Medical Center

Enrollment

150 participants

Start Date

Oct 7, 2024

Study Type

INTERVENTIONAL

Conditions

Orbital EdemaOrbital Ecchymosis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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
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Interventions

DRUGTranexamic acid injection

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

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

1g IV TXA

DRUGnormal saline - injection

0.9% Normal Saline injection in the orbit

DRUGnormal saline - intravenous

0.9% IV Normal Saline

Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT06450392