Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery

NCT07131592 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025P001908
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drain Output After Breast Reduction Surgery; Breast Reductions

Keywords

TXA; Tranexamic Acid; Breast Reduction; Postoperative Drainaige; Plastic Surgery; Randomized Controlled Trial; RCT

Outcome Measures

Primary Outcomes (2)

• Total drain output per breast per 24 hours post-surgery (mL) until drain removal

  Drain outputs will be recorded separately for each breast twice daily until removal.

  From date of operation until drain removal up to 4 weeks.

• Time to drain removal (days)

  Drains will be removed per standard protocol by trained staff if the output is ≤30 mL in a 24-hour period for two consecutive days. The time to drain removal will be recorded.

  From date of operation until drain removal up to 4 weeks.

Secondary Outcomes (9)

• Change in drain fluid color from bloody to serous until drain removal assessed by daily observation

  From postoperative Day 1 until drain removal, up to 4 weeks after surgery

• Seroma Rate

  From date of surgery until end of study (30 days postoperative).

• Infection Rate

  From date of surgery until end of study (30 days postoperative).

• Hematoma Rate

  From date of surgery until end of study (30 days postoperative).

• Wound Dehiscence Rate

  From date of surgery until end of study (30 days postoperative).

Study Arms (4)

IV TXA + Topical TXA

EXPERIMENTAL

Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with topical TXA administered through the surgical drain.

Drug: IV TXA; Drug: Topical TXA

IV TXA + Topical Saline

ACTIVE COMPARATOR

Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with saline administered through the surgical drain.

Drug: IV TXA; Drug: Topical saline

No IV TXA + Topical TXA

EXPERIMENTAL

Participants in this arm receive no intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with TXA administered through the surgical drain.

Drug: Topical TXA

No IV TXA + Topical Saline

PLACEBO COMPARATOR

Participants in this arm receive no intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with saline administered through the surgical drain.

Drug: Topical saline

Interventions

IV TXA DRUG

Patients randomized to the IV TXA group will receive intravenous Tranexamic acid during the procedure. The dose will be 1g IV infused over approx. 10 minutes prior to skin closure (dosing of approx. 15 mg/kg, capped at 1 g, which is within safe limits).

IV TXA + Topical Saline; IV TXA + Topical TXA

Topical TXA DRUG

Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized topical TXA intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the TXA to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.

Also known as: Topical Tranexamic acid, Topical TXA through drain

IV TXA + Topical TXA; No IV TXA + Topical TXA

Topical saline DRUG

Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized saline intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the saline to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.

Also known as: Topical 0.9% Sodium Chloride, Topical Placebo

IV TXA + Topical Saline; No IV TXA + Topical Saline

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Elective bilateral breast reduction
• Patient understands and is willing to participate in the study
• Patient willing to and capable of providing informed consent

You may not qualify if:

• Age less than 18 years old
• Prior radiation to the breast
• Secondary/Revision breast reduction
• Known coagulopathy or bleeding disorders
• Intraoperative coagulopathy
• History of seizures
• Active smokers
• Allergy or contraindication to TXA
• Pregnant or breastfeeding patients
• Patient is unable or unwilling to complete the anticipated study follow-up
• Inability to understand the aims and objectives of the study
• Inability to or unwilling to provide informed consent

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (14)

• 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.

  PMID: 36856723 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.

  PMID: 26349843 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.

  PMID: 36827482 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.

  PMID: 36729428 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.

  PMID: 39518646 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.

  PMID: 40395663 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.

  PMID: 40156946 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.

  PMID: 36729851 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.

  PMID: 39924382 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.

  PMID: 22611164 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.

  PMID: 10400410 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.

  PMID: 28398469 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.

  PMID: 35568688 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.

  PMID: 40575008 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MS, Primary Investigator, Assistant Professor, Division of Plastic and Reconstructive Surgery, Department of Surgery, Massachusetts General Hospital and Harvard Medical School, Boston, MA

Model Details: Participants are randomized to either receive intravenous tranexamic acid (TXA) or no TXA during bilateral breast reduction surgery. Within each participant, a split-breast design is applied: one breast is treated with topical TXA through the surgical drain, while the contralateral breast receives saline

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 20, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)