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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Suspended to Recruiting
    • Site details revised
    v7
  2. Stopped Trial status: Recruiting to Suspended Sponsor's reason: Study suspend, pending IRB re-approval
    • Site details revised
    v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Oct 7, 2024
    • Site details revised
    v5
  4. Minor Primary and study completion dates: Dec 2026 to Jan 2027
    • Start date: Aug 2024 to Sep 2024
    v4
  5. Minor Start date: Jul 2024 to Aug 2024v3
  6. Minor Study sites: 0 to 1v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06450392
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)
Orbital Edema, Orbital Ecchymosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov