drugset / Trial / NCT04951128
The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery
RandomizedSingle-groupTriple-blindTreatment
Summary
Tranexamic acid (TXA) is a synthetic inhibitor of plasminogen lysine receptor that has used to reduce intra-operative bleeding in a number of clinical scenarios. Anecdotally, TXA has used by plastic surgeons to reduce post-operative bruising. To date, there is limited data to valid the benefits and to evaluate the side effects of TXA. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.
Timeline
- Start
- 2021-08-01
- Primary completion
- 2021-12-31
- Completion
- 2022-07-01
Publications
- Background Rohrich RJ, Cho MJ. The Role of Tranexamic Acid in Plastic Surgery: Review and Technical Considerations. Plast Reconstr Surg. 2018 Feb;141(2):507-515. doi: 10.1097/PRS.0000000000003926.
- Background Lukes AS, Moore KA, Muse KN, Gersten JK, Hecht BR, Edlund M, Richter HE, Eder SE, Attia GR, Patrick DL, Rubin A, Shangold GA. Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010 Oct;116(4):865-875. doi: 10.1097/AOG.0b013e3181f20177.
- Background CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Background CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.
- Background Morrison JJ, Dubose JJ, Rasmussen TE, Midwinter MJ. Military Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study. Arch Surg. 2012 Feb;147(2):113-9. doi: 10.1001/archsurg.2011.287. Epub 2011 Oct 17.
- Background Gungorduk K, Yildirim G, Asicioglu O, Gungorduk OC, Sudolmus S, Ark C. Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study. Am J Perinatol. 2011 Mar;28(3):233-40. doi: 10.1055/s-0030-1268238. Epub 2010 Oct 26.
- Background Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7.
- Background Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060.
- Background Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23.
- Background Choi HY, Hyun SJ, Kim KJ, Jahng TA, Kim HJ. Effectiveness and Safety of Tranexamic Acid in Spinal Deformity Surgery. J Korean Neurosurg Soc. 2017 Jan 1;60(1):75-81. doi: 10.3340/jkns.2016.0505.004. Epub 2016 Dec 29.
- Background Choi WS, Irwin MG, Samman N. The effect of tranexamic acid on blood loss during orthognathic surgery: a randomized controlled trial. J Oral Maxillofac Surg. 2009 Jan;67(1):125-33. doi: 10.1016/j.joms.2008.08.015.
- Background Kumsar S, Dirim A, Toksoz S, Saglam HS, Adsan O. Tranexamic acid decreases blood loss during transurethral resection of the prostate (TUR -P). Cent European J Urol. 2011;64(3):156-8. doi: 10.5173/ceju.2011.03.art13. Epub 2011 Sep 6.
- Background Rannikko A, Petas A, Taari K. Tranexamic acid in control of primary hemorrhage during transurethral prostatectomy. Urology. 2004 Nov;64(5):955-8. doi: 10.1016/j.urology.2004.07.008.
- Background Hillman J, Fridriksson S, Nilsson O, Yu Z, Saveland H, Jakobsson KE. Immediate administration of tranexamic acid and reduced incidence of early rebleeding after aneurysmal subarachnoid hemorrhage: a prospective randomized study. J Neurosurg. 2002 Oct;97(4):771-8. doi: 10.3171/jns.2002.97.4.0771.
- Background Zahed R, Mousavi Jazayeri MH, Naderi A, Naderpour Z, Saeedi M. Topical Tranexamic Acid Compared With Anterior Nasal Packing for Treatment of Epistaxis in Patients Taking Antiplatelet Drugs: Randomized Controlled Trial. Acad Emerg Med. 2018 Mar;25(3):261-266. doi: 10.1111/acem.13345. Epub 2017 Dec 9.
- Background Wand O, Guber E, Guber A, Epstein Shochet G, Israeli-Shani L, Shitrit D. Inhaled Tranexamic Acid for Hemoptysis Treatment: A Randomized Controlled Trial. Chest. 2018 Dec;154(6):1379-1384. doi: 10.1016/j.chest.2018.09.026. Epub 2018 Oct 12.
- Background Sagiv O, Rosenfeld E, Kalderon E, Barazani TB, Zloto O, Martinowitz U, Ben Simon GJ, Zilinsky I. Subcutaneous tranexamic acid in upper eyelid blepharoplasty: a prospective randomized pilot study. Can J Ophthalmol. 2018 Dec;53(6):600-604. doi: 10.1016/j.jcjo.2018.01.006. Epub 2018 Mar 27.
- Background Butz DR, Geldner PD. The Use of Tranexamic Acid in Rhytidectomy Patients. Plast Reconstr Surg Glob Open. 2016 May 25;4(5):e716. doi: 10.1097/GOX.0000000000000745. eCollection 2016 May. No abstract available.
- Background Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.
- Background Sakallioglu O, Polat C, Soylu E, Duzer S, Orhan I, Akyigit A. The efficacy of tranexamic acid and corticosteroid on edema and ecchymosis in septorhinoplasty. Ann Plast Surg. 2015 Apr;74(4):392-6. doi: 10.1097/SAP.0b013e3182a1e527.
- Background Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs. 2003;63(13):1417-33. doi: 10.2165/00003495-200363130-00008.
- Background Berntorp E, Follrud C, Lethagen S. No increased risk of venous thrombosis in women taking tranexamic acid. Thromb Haemost. 2001 Aug;86(2):714-5. No abstract available.
- Background Lindoff C, Rybo G, Astedt B. Treatment with tranexamic acid during pregnancy, and the risk of thrombo-embolic complications. Thromb Haemost. 1993 Aug 2;70(2):238-40.
- Background Tavakoli N, Mokhtare M, Agah S, Azizi A, Masoodi M, Amiri H, Sheikhvatan M, Syedsalehi B, Behnam B, Arabahmadi M, Mehrazi M. Comparison of the efficacy of intravenous tranexamic acid with and without topical administration versus placebo in urgent endoscopy rate for acute gastrointestinal bleeding: A double-blind randomized controlled trial. United European Gastroenterol J. 2018 Feb;6(1):46-54. doi: 10.1177/2050640617714940. Epub 2017 Jun 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 0.5 ml | Other |
| Subject | Tranexamic Acid | Small molecule | 100 mg/ml | Other |
| Background | Bupivacaine | Other / unclassified | 0.5 % | — |
| Background | Bupivacaine | Other / unclassified | 2.25 ml | — |
| Background | Bupivacaine | Other / unclassified | 2.5 ml | — |
| Background | Epinephrine | Other / unclassified | — | — |
| Background | Lidocaine | Other / unclassified | 2 % | — |
| Background | Lidocaine | Other / unclassified | 2.25 ml | — |
| Background | Lidocaine | Other / unclassified | 2.5 ml | — |