drugset / Trial / NCT07131592
Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery
RandomizedParallel-groupSingle-blindTreatment
Summary
This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction surgery. Participants will be randomly assigned to receive either intravenous TXA or no TXA during surgery. Additionally, one breast will receive TXA through the surgical drain, while the other will receive saline. This approach allows to compare the effects of TXA on fluid buildup and healing. The goal is to improve recovery and reduce complications after breast reduction surgery.
Timeline
- Start
- 2025-11-18
- Primary completion
- 2027-03-01
- Completion
- 2027-08-31
Publications
- Background Nichols G, Andrade E, Gregoski M, Herrera FA, Armstrong MB. Local Infiltration of Tranexamic Acid in Breast Reduction for Symptomatic Macromastia. Ann Plast Surg. 2023 Jun 1;90(6S Suppl 4):S366-S370. doi: 10.1097/SAP.0000000000003456. Epub 2023 Feb 18.
- 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 Safran T, Vorstenbosch J, Viezel-Mathieu A, Davison P, Dionisopoulos T. Topical Tranexamic Acid in Breast Reconstruction: A Double-Blind Randomized Controlled Trial. Plast Reconstr Surg. 2023 Oct 1;152(4):699-706. doi: 10.1097/PRS.0000000000010322. Epub 2023 Feb 27.
- Background Liechti R, van de Wall BJM, Hug U, Fritsche E, Franchi A. Tranexamic Acid Use in Breast Surgery: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2023 May 1;151(5):949-957. doi: 10.1097/PRS.0000000000010071. Epub 2022 Dec 19.
- Background Guggenheim L, Magni S, Catic A, Pagnamenta A, Harder Y, Schmauss D. The Effects of Systemic Tranexamic Acid Administration on Drainage Volume, Duration of Drain Placement, and Length of Hospital Stay in Skin- and Nipple-Sparing Mastectomies with Immediate Expander-Based Breast Reconstruction. J Clin Med. 2024 Oct 30;13(21):6507. doi: 10.3390/jcm13216507.
- Background Zucal I, De Pellegrin L, Pagnamenta A, Schmauss D, Brucato D, De Monti M, Schweizer R, Harder Y, Parodi C. Topical Application of Tranexamic Acid in Abdominoplasties Leads to Lower Drainage Volume and Earlier Drain Removal. Plast Reconstr Surg Glob Open. 2025 May 20;13(5):e6799. doi: 10.1097/GOX.0000000000006799. eCollection 2025 May.
- Background Fung E, Godek M, Roth JM, Montalmant KE, Yu BZ, Henderson PW. The current state of tranexamic acid in mastectomy and breast reconstruction: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2025 May;104:259-272. doi: 10.1016/j.bjps.2025.03.022. Epub 2025 Mar 12.
- Background Om A, Marxen T, Kebede S, Losken A. The Usage of Intravenous Tranexamic Acid in Reduction Mammaplasty Safely Reduces Hematoma Rates. Ann Plast Surg. 2023 Jun 1;90(6S Suppl 4):S371-S374. doi: 10.1097/SAP.0000000000003296. Epub 2022 Dec 8.
- Background Buheiri AR, Tveskov L, Dines LM, Bagge JD, Moller S, Bille C. Tranexamic Acid in Breast Surgery - A Systematic Review and Meta-Analysis. Clin Breast Cancer. 2025 Jul;25(5):e496-e510. doi: 10.1016/j.clbc.2025.01.011. Epub 2025 Jan 23.
- Background Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
- Background Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
- Background Kaoutzanis C, Winocour J, Gupta V, Ganesh Kumar N, Sarosiek K, Wormer B, Tokin C, Grotting JC, Higdon KK. Incidence and Risk Factors for Major Hematomas in Aesthetic Surgery: Analysis of 129,007 Patients. Aesthet Surg J. 2017 Oct 16;37(10):1175-1185. doi: 10.1093/asj/sjx062.
- Background Yao A, Yi J, Greige N, Chemakin K, Weichman KE, Ricci JA. Effect of intraoperative blood pressure on incidence of hematoma in breast reduction mammoplasty. J Plast Reconstr Aesthet Surg. 2022 Aug;75(8):2594-2600. doi: 10.1016/j.bjps.2022.04.014. Epub 2022 Apr 22.
- Background Alhebshi ZA, Sabbagh SR, AlQurain ZJ, Bamuqabel AO, Dahlan DJ, Rajoub RA, Fallatah DO, Rajoub BA, Wasaya HMI, Fallatah E. The Role of Tranexamic Acid Use in Reduction Mammaplasty: A Systematic Review and Meta-Analysis. Aesthet Surg J Open Forum. 2025 May 3;7:ojaf035. doi: 10.1093/asjof/ojaf035. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1 g | Intravenous |
Indications
No indication recorded.