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

Conditions

• Orbital Ecchymosis
• Orbital Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tranexamic acid injection — DRUG
  100 mg/mL (manufactured concentration) local TXA injection in the orbit
• Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML) — DRUG
  1g IV TXA
• normal saline - injection — DRUG
  0.9% Normal Saline injection in the orbit
• normal saline - intravenous — DRUG
  0.9% IV Normal Saline

Study Details

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.

Key Dates

Start date

Oct 7, 2024

Status verified

Dec 2025

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1: IV TXA
  1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery
• Experimental: Group 2: Local TXA
  1-2mL of subcutaneous tranexamic acid 100 mg/mL (manufactured concentration, Pfizer, New York, NY) mixed with local anesthetic to the orbit two minutes prior to incision
• Placebo Comparator: Group 3: Control
  Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group

Primary Outcome Measure

Degree of Ecchymosis [ Time Frame: 0 days and 7 days postoperatively ]

Central Contacts

• Anne Barmettler
  718-920-4609
  [email protected]

Locations (1)

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