drugset / Trial / NCT06450392
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2024-10-07
- Primary completion
- 2027-01
- Completion
- 2027-01
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 100 mg/ml | Subcutaneous |
| Subject | Tranexamic Acid | Small molecule | 1 g | Subcutaneous |