NCT05945680

Tranexamic Acid in Breast Esthetic Surgery.

The Effectiveness of Tranexamic Acid in Breast Esthetic Surgery.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Poznan University of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hemorrhage
• Bleeding

Interventions

Type	Name	Description
DRUG	Placebo	100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
DRUG	Tranexamic acid	Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-07-14
• Last updated: 2025-11-25

Locations

1 site across 1 country: Poland