Clinical trial NCT04951128: The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery
Official title: The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Edema
Ecchymosis; Eyelid
Keywords: Tranexamic acid
Post-operative ecchymosis
Post-operative edema
Lead sponsor: Consultants in Ophthalmic and Facial Plastics Surgery
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reduce bleeding. Recent studies have demonstrated the antifibrinolytic benefits of TXA in a number of clinical scenarios, including heavy menstrual bleeding, traumatic hemorrhage, elective cesarean section, total knee arthroplasty, coronary artery surgery, spinal deformity surgery, orthognathic surgery, transurethral prostate resection, aneurysmal subarachnoid hemorrhage, epistaxis, and hemoptysis.

Anecdotally, TXA has been used by plastic surgeons to reduce postoperative bruising. However, there is a paucity of clinical data on TXA use in plastic surgery, and the results are inconsistent. In a prospective randomized controlled trial evaluating local TXA in upper blepharoplasty, Sagiv et al reported no intraoperative blood loss, surgeon's assessment of hemostasis, and periocular ecchymosis size on postoperative day 1. Butz and Geldner reviewed their experience placing TXA-soaked pledgets in 57 patients who underwent face lift18. They identified only 1 patient who had post-operative hematoma and they reported no systemic complications from TXA use. In a randomized control trial evaluating topical TXA in reduction mammoplasty, Ausen et al reported 39% reduction of postoperative fluid drainage on the treatment side. In a study evaluating oral TXA and cortisone effect in rhinoplasty, Sakalliogu et al reported significant reduction of intraoperative bleeding and postoperative ecchymosis/edema in patients who underwent rhinoplasty. Further study is warranted to evaluate the use to TXA in plastic surgery. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years old
* Undergo bilateral upper/lower eyelid blepharoplasty, bilateral upper eyelid ptosis repair, or a combination of the above procedures
* Additional concurrent forehead/brow or upper/lower eyelids surgeries may be included if bilateral

Exclusion Criteria:

* Prior eyelid surgery
* Anticoagulant or antiplatelet use, including aspirin, within 7 days prior to surgery
* Patient who is currently pregnant or breast feeding
* Patient with color vision deficiency
* TXA allergy
* History of bleeding disorder
* History of clotting disorder
* History of seizure
* Have active nausea/vomiting/gastrointestinal symptoms
* Have active intracranial bleeding
* Have active periocular ecchymosis or edema prior to surgery

Primary outcomes:
measure: Post-operative edema/ecchymosis
timeFrame: 1st post op visit: post-op day 1 to 3
measure: Post-operative edema/ecchymosis
timeFrame: 2nd post op visit: post-op day 7 to 10
Secondary outcomes:
measure: Post-operative complications
timeFrame: 1st post op visit: post-op day 1 to 3
measure: Post-operative complications
timeFrame: 2nd post op visit: post-op day 7 to 10
Other outcomes:
Locations:
city: Southfield
country: United States
facility: Consultants in Ophthalmic and Facial Plastic Surgery
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: University of Texas - Health Science Center at Houston
state: Texas
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.