Tranexamic Acid in Breast Esthetic Surgery.

The Effectiveness of Tranexamic Acid in Breast Esthetic Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Bleeding
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic acid

Detailed Description

Tranexamic acid (TXA) treatment is increasingly emphasized in plastic surgery because TXA inhibits fibrinolysis. Increased clot stability offers the possibility of preventing blood loss (prevention) and mitigating ongoing hemorrhage. TXA therapy has been principally studied in populations; the results of studies in plastic surgery still need to be improved.

Tranexamic acid is an antifibrinolytic agent that acts as a competitive inhibitor at the lysine binding sites of plasminogen and inhibits the ability of protease plasmin to cleave the fibrin clot. In large randomized controlled trials, it has been reported to be effective in decreasing perioperative blood loss in various circumstances, primarily involving trauma patients.

The investigators designed a randomized placebo-controlled trial comparing TXA dosing before incision for breast esthetic surgery. The purpose is to quantify blood loss during plastic surgery with and without TXA.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland
    • Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid; Tranexamic Acid for intravenous administration.	Drug: Tranexamic acid; Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.; Other Names: TXA
Placebo Comparator: Placebo; Normal saline for intravenous administration.	Drug: Placebo; 100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.; Other Names: 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss volume	Total blood volume loss will be calculated in milliliters.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBG	Hemoglobin level measured before and 24 hours after surgery	24 hours after surgery
D-dimer	D-dimer level measured before and 24 hours after surgery	24 hours after surgery
Fibrinogen	Fibrinogen level measured before and 24 hours after surgery	24 hours after surgery

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Małgorzata Domagalska, Ph.D., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Organic Chemicals; Carboxylic Acids; Inorganic Chemicals; Chlorine Compounds; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Sodium Compounds; Chlorides; Hydrochloric Acid; Tranexamic Acid; Sodium Chloride
• Other Study ID Numbers: 17/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No