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

NCT06450392 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2024-15945
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orbital Edema; Orbital Ecchymosis

Keywords

Orbital Surgery

Outcome Measures

Primary Outcomes (2)

• Degree of Ecchymosis

  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.

  0 days and 7 days postoperatively

• Degree of Edema

  Degree of edema 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 edema.

  0 days and 7 days postoperatively

Secondary Outcomes (3)

• Patient Satisfaction with edema

  7 days postoperatively

• Patient Satisfaction with ecchymosis

  7 days postoperatively

• Other side effects

  7 days postoperatively

Study Arms (3)

Group 1: IV TXA

EXPERIMENTAL

1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery

Drug: Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML); Drug: normal saline - injection

Group 2: Local TXA

EXPERIMENTAL

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

Drug: Tranexamic acid injection; Drug: normal saline - intravenous

Group 3: Control

PLACEBO COMPARATOR

Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group

Drug: normal saline - injection; Drug: normal saline - intravenous

Interventions

normal saline - injection DRUG

0.9% Normal Saline injection in the orbit

Group 1: IV TXA; Group 3: Control

normal saline - intravenous DRUG

0.9% IV Normal Saline

Group 2: Local TXA; Group 3: Control

Tranexamic acid injection DRUG

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

Group 2: Local TXA

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

1g IV TXA

Group 1: IV TXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (8)

• Kono S, Lee PAL, Kakizaki H, Takahashi Y. Orbital haematoma after orbital fracture repair using silicone, polytetrafluorethylene, and poly-L-lactic acid/hydroxyapatite implants. Br J Oral Maxillofac Surg. 2021 Nov;59(9):1036-1039. doi: 10.1016/j.bjoms.2021.01.002. Epub 2021 Jan 15.

  PMID: 34531075 BACKGROUND

• Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7.

  PMID: 34626756 BACKGROUND

• Paramo R, Cheng T, Malik A, Fan J, Barmettler A. Effect of Tranexamic Acid on Intra- and Postoperative Bleeding in Eyelid Surgery: A Prospective, Randomized, Multicenter, Double-Masked, Control Trial. Ophthalmic Plast Reconstr Surg. 2024 May-Jun 01;40(3):331-335. doi: 10.1097/IOP.0000000000002583. Epub 2024 Apr 12.

  PMID: 38624153 BACKGROUND

• Marous CL, Farhat OJ, Cefalu M, Rothschild MI, Alapati S, Wladis EJ. Effects of Preoperative Intravenous Versus Subcutaneous Tranexamic Acid on Postoperative Periorbital Ecchymosis and Edema Following Upper Eyelid Blepharoplasty: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Comparative Study. Ophthalmic Plast Reconstr Surg. 2024 Sep-Oct 01;40(5):523-532. doi: 10.1097/IOP.0000000000002633. Epub 2024 Apr 29.

  PMID: 38687303 BACKGROUND

• Artymowicz, A., & Shinder, R. (2022). Effect of subcutaneous tranexamic acid on hemostasis and ecchymosis in dacryocystorhinostomy: A double-blind, placebo-controlled, randomized clinical trial. Poster session presented at the ASOPRS 2022 Conference, Chicago, IL, United States.

  BACKGROUND

• Zilinsky I, Barazani TB, Shenkman B, Weisman O, Farber N, Martinowitz U. Topical Hemostatic-Anesthetic Solution to Reduce Bleeding During Mohs Micrographic Surgery: A Case Control Study. J Drugs Dermatol. 2016 Jul 1;15(7):851-5.

  PMID: 27391635 BACKGROUND

• Horrow JC, Van Riper DF, Strong MD, Grunewald KE, Parmet JL. The dose-response relationship of tranexamic acid. Anesthesiology. 1995 Feb;82(2):383-92. doi: 10.1097/00000542-199502000-00009.

  PMID: 7856897 BACKGROUND

• Schroeder RJ 2nd, Langsdon PR. Effect of Local Tranexamic Acid on Hemostasis in Rhytidectomy. Facial Plast Surg Aesthet Med. 2020 May/Jun;22(3):195-199. doi: 10.1089/fpsam.2020.0061. Epub 2020 Mar 31.

  PMID: 32228311 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anne Barmettler

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Barmettler

CONTACT

718-920-4609; abarmett@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, randomized, double-blinded, controlled trial. On the day of surgery in the preoperative suite, study participants will be randomly allocated to one of three groups via computer-generated random numbers as described in the Arms and Interventions section.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)