Recruiting

TXA with Saline

Sponsor:

Massachusetts General Hospital

Code:

NCT07131592

Conditions

Drain Output After Breast Reduction Surgery

Breast Reductions

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IV TXA

Topical TXA

Topical saline

Study Details

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

Study ID

NCT07131592

Start date

Nov 18, 2025

Status verified date

Jan, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IV TXA + Topical TXA

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.

active comparator: IV TXA + Topical Saline

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.

experimental: No IV TXA + Topical TXA

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.

placebo comparator: No IV TXA + Topical Saline

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.

Interventions

IV TXA

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).

Topical TXA

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.

Topical saline

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.

Primary outcome measure

  • Total drain output per breast per 24 hours post-surgery (mL) until drain removal [ Time Frame: From date of operation until drain removal up to 4 weeks. ]
  • Time to drain removal (days) [ Time Frame: From date of operation until drain removal up to 4 weeks. ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Katherine H Carruthers, MD

617-643-7294khcarruthers@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-01-16.