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NCT06450392 · ClinicalTrials.gov registry record · Phase 4
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
A Phase 4 study of Orbital Edema and Orbital Ecchymosis, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06450392: Recruiting Phase 4 study of Orbital Edema and Orbital Ecchymosis, sponsored by Montefiore Medical Center.
NCT06450392 is a Phase 4 study of Orbital Edema and Orbital Ecchymosis that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06450392, a Phase 4 study of Orbital Edema and Orbital Ecchymosis, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Degree of ecchymosis on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of ecchymosis.
Conditions Studied
Interventions
- DRUG Tranexamic acid injection
- DRUG Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)
- DRUG normal saline - injection
- DRUG normal saline - intravenous
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-10-07 |
| Est. Completion | 2027-01 |
| Phase | Phase 4 |
What NCT06450392 shows while recruiting
NCT06450392 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Orbital Edema appearing as the primary indexed condition, and to 4 interventions - of which Tranexamic acid injection is the first listed.
NCT06450392 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06450392 about?
NCT06450392 is a clinical study titled "The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery". 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 co...
What is the current status of trial NCT06450392?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2024-10-07. Estimated completion is 2027-01.
What conditions does trial NCT06450392 study?
This clinical trial studies the following conditions: Orbital Edema, Orbital Ecchymosis.
What interventions are being tested in trial NCT06450392?
The interventions under investigation include: Tranexamic acid injection (DRUG), Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML) (DRUG), normal saline - injection (DRUG), normal saline - intravenous (DRUG).
Who is sponsoring clinical trial NCT06450392?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06450392 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06450392's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,437 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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