Drain Output After Breast Reduction SurgeryPhase 4NCT07131592

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

A Phase 4 study testing IV TXA, Topical TXA and Topical saline in people with Drain Output After Breast Reduction Surgery and Breast Reductions, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Drain Output After Breast Reduction Surgery, Breast Reductions
What is being tested?: IV TXA, Topical TXA and Topical saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteUnited States
Study dates: 18 Nov 2025to 31 Aug 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

Massachusetts General Hospital
Boston, Massachusetts, 02114
Katherine H Carruthers, MD, 617-643-7294, khcarruthers@mgh.harvard.edu
Recruiting

Other trials in United States

About this study

Official title: The Effect of Tranexamic Acid on Drainage Volume and Time to Drain Removal in Reduction Mammaplasty Patients

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.

Read the detailed description

This single-center, prospective, randomized controlled trial investigates the effect of tranexamic acid (TXA) on postoperative drain output and recovery following bilateral reduction mammaplasty. While TXA is widely utilized to minimize intraoperative blood loss, its role in optimizing postoperative wound healing and fluid management in plastic surgery remains underexplored.

Participants undergoing bilateral breast reduction will be randomized to receive either intravenous TXA or no TXA at the time of surgery. In addition, each breast will be independently randomized to receive TXA or saline via the closed-suction drain after skin closure. This split-body design enables a controlled intra-individual comparison of local TXA effects, while concurrently assessing systemic administration in a parallel fashion.

Primary outcomes include total drain output per breast and time to drain removal. Secondary endpoints include the incidence of postoperative hematoma and patient reported outcomes. All outcome measures will be recorded using standardized protocols and assessed by blinded evaluators where applicable.

Participants will be followed until 30 days postoperatively.

Given the established safety profile of TXA and the relatively low-risk nature of the intervention, no independent data monitoring committee has been appointed. The study has been approved by the local IRB and will adhere to institutional standards for adverse event monitoring and reporting.

Conditions: Drain Output After Breast Reduction Surgery, Breast Reductions
Being tested: IV TXA, Topical TXA, Topical saline
Keywords: TXA, Tranexamic Acid, Breast Reduction, Postoperative Drainaige, Plastic Surgery, Randomized Controlled Trial, RCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IV TXADrug
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 TXADrug
Also called Topical Tranexamic acid, Topical TXA through drain
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 salineDrug
Also called Topical 0.9% Sodium Chloride, Topical Placebo
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.

Study groups in NCT07131592
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Topical saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Qualitative change in drain fluid from bloody to serous. Measured by daily observation by clinical staff until drain removal. Change will be recorded as transition from bloody to serous.
Measured: From postoperative Day 1 until drain removal, up to 4 weeks after surgery
Seroma Rate
Rate of clinically evident seromas in the postoperative follow-up period. Diagnosis will be based on physical examination and/or ultrasound when clinically indicated.
Measured: From date of surgery until end of study (30 days postoperative).
Infection Rate
Rate of surgical site infections (superficial or deep) diagnosed based on CDC criteria during the postoperative period.
Measured: From date of surgery until end of study (30 days postoperative).
Hematoma Rate
Rate of postoperative hematoma formation. Diagnosis will be based on physical examination and/or via imaging, if clinically indicated.
Measured: From date of surgery until end of study (30 days postoperative).
Wound Dehiscence Rate
Rate of postoperative wound dehiscence identified clinically, including any spontaneous reopening of the surgical incision.
Measured: From date of surgery until end of study (30 days postoperative).
Length of Hospital Stay
Duration of inpatient stay postoperatively, measured in days from the date of surgery to the date of discharge.
Measured: From date of surgery until discharge from the hospital up to 4 weeks.
30-Day Readmission Rate
Rate of patients readmitted to the hospital within 30 days of the index surgery, regardless of cause.
Measured: From date of surgery until end of study (30 days postoperative)
30-Day Revision Rate
Rate of reoperation or revision procedures performed within 30 days postoperatively due to complications.
Measured: From date of surgery until end of study (30 days postoperative).
Patient-Reported Outcomes (BREAST-Q Breast Reduction Module)
The BREAST-Q Breast Reduction Module is a validated patient-reported outcome measure assessing satisfaction and quality of life following breast reduction surgery. Each subscale is scored from 0 to 100, with higher scores indicating greater satisfaction and/or better quality of life.
Measured: Preoperative before surgery, 7 days after and 30 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202531 Aug 2027

First posted20 Aug 2025
Study start18 Nov 2025
Primary completion1 Mar 2027 (estimated)
Study completion31 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Drain Output After Breast Reduction SurgeryStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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
Masking: Single blind
Who is masked: Participant
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07131592
Sponsor's protocol ID: 2025P001908
Status last verified: Jan 2026
First submitted: 5 Aug 2025
Last updated: 16 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: The investigators do not plan to share individual participant data (IPD) due to institutional and ethical constraints. The informed consent documents did not include provisions for external data sharing, and the dataset contains sensitive clinical information that could pose a risk of re-identification, despite de-identification efforts.

Publications

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.
PubMed 36856723
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.
PubMed 26349843
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.
PubMed 36827482
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.
PubMed 36729428
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.
PubMed 39518646
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.
PubMed 40395663
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.
PubMed 40156946
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.
PubMed 36729851
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.
PubMed 39924382
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.
PubMed 22611164
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.
PubMed 10400410
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.
PubMed 28398469
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.
PubMed 35568688
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.
PubMed 40575008

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Tranexamic Acid on Drainage Volume and Time to Drain Removal in Reduction Mammaplasty Patients
ClinicalTrials.gov ID: NCT07131592
Acronym / sponsor ID: 2025P001908
Conditions: Drain Output After Breast Reduction Surgery, Breast Reductions
Keywords: TXA, Tranexamic Acid, Breast Reduction, Postoperative Drainaige, Plastic Surgery, Randomized Controlled Trial, RCT
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 160 participants (estimated)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 18 Nov 2025 (actual)
Primary completion: 1 Mar 2027 (estimated)
Study completion: 31 Aug 2027 (estimated)
First posted: 20 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants will be followed until 30 days postoperatively.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: 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

Arm	Type	Receives
IV TXA + Topical TXA	Experimental	Drug: IV TXA, Drug: Topical TXAParticipants 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.
IV TXA + Topical Saline	Active comparator	Drug: IV TXA, Drug: Topical salineParticipants 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.
No IV TXA + Topical TXA	Experimental	Drug: Topical TXAParticipants 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.
No IV TXA + Topical Saline	Placebo comparator	Drug: Topical salineParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (12 listed)

Age less than 18 years old
Prior radiation to the breast
Secondary/Revision breast reduction
Known coagulopathy or bleeding disorders
Intraoperative coagulopathy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IV TXAPatients 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).	Drug	IV TXA + Topical Saline, IV TXA + Topical TXA
Topical TXAAlso: Topical Tranexamic acid, Topical TXA through drainBefore 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.	Drug	IV TXA + Topical TXA, No IV TXA + Topical TXA
Topical salineAlso: Topical 0.9% Sodium Chloride, Topical PlaceboBefore 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.	Drug	IV TXA + Topical Saline, No IV TXA + Topical Saline

Primary outcome

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.
Drain outputs will be recorded separately for each breast twice daily until removal.
Time to drain removal (days)
Time frame: From date of operation until drain removal up to 4 weeks.
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.

9 secondary outcomes

Change in drain fluid color from bloody to serous until drain removal assessed by daily observation
Time frame: From postoperative Day 1 until drain removal, up to 4 weeks after surgery
Seroma Rate
Time frame: From date of surgery until end of study (30 days postoperative).
Infection Rate
Time frame: From date of surgery until end of study (30 days postoperative).
Hematoma Rate
Time frame: From date of surgery until end of study (30 days postoperative).
Wound Dehiscence Rate
Time frame: From date of surgery until end of study (30 days postoperative).
Length of Hospital Stay
Time frame: From date of surgery until discharge from the hospital up to 4 weeks.
30-Day Readmission Rate
Time frame: From date of surgery until end of study (30 days postoperative)
30-Day Revision Rate
Time frame: From date of surgery until end of study (30 days postoperative).
Patient-Reported Outcomes (BREAST-Q Breast Reduction Module)
Time frame: Preoperative before surgery, 7 days after and 30 days after surgery.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Background: PubMed 36856723Nichols 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: PubMed 26349843Ausen 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: PubMed 36827482Safran 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: PubMed 36729428Liechti 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: PubMed 39518646Guggenheim 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: PubMed 40395663Zucal 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: PubMed 40156946Fung 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: PubMed 36729851Om 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: PubMed 39924382Buheiri 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: PubMed 22611164Ker 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: PubMed 10400410Dunn 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: PubMed 28398469Kaoutzanis 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.
Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data (IPD) due to institutional and ethical constraints. The informed consent documents did not include provisions for external data sharing, and the dataset contains sensitive clinical information that could pose a risk of re-identification, despite de-identification efforts.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Massachusetts General Hospital

Boston, United States

617-643-7294

khcarruthers@mgh.harvard.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07131592, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.