NCT05945680

Brief Summary

The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing breast esthetic surgery. This study aims to quantify blood loss during abdominoplasty with and without TXA. The central hypothesis is that TXA administration reduces blood loss and fibrinolysis in breast esthetic surgery patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

November 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

July 6, 2023

Last Update Submit

November 19, 2025

Conditions

HemorrhageBleeding

Outcome Measures

Primary Outcomes (1)

  • Blood loss volume

    Total blood volume loss will be calculated in milliliters.

    24 hours after surgery

Secondary Outcomes (3)

  • HBG

    24 hours after surgery

  • D-dimer

    24 hours after surgery

  • Fibrinogen

    24 hours after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline for intravenous administration.

Drug: Placebo

Tranexamic acid

ACTIVE COMPARATOR

Tranexamic Acid for intravenous administration.

Drug: Tranexamic acid

Interventions

PlaceboDRUG

100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.

Also known as: 0.9% sodium chloride
Placebo
Tranexamic acidDRUG

Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.

Also known as: TXA
Tranexamic acid

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadult women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women scheduled for breast esthetic surgery
  • ASA 1 or 2
  • age \>18 and \<75 years

You may not qualify if:

  • BMI \<20 or \>35 kg/m2
  • ASA 3 or \> 3
  • medical history of thromboembolism
  • history of hematological disease
  • treatment with aspirin 14 days before the procedure
  • treatment with anticoagulants 5 days before the procedure
  • epilepsy
  • allergy to tranexamic acid
  • coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Poland

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Sodium ChlorideTranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Małgorzata Domagalska, Ph.D.

    Poznań University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

September 15, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

November 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)