Tranexamic Acid in Breast Esthetic Surgery.

Bleeding Clinical Trial

Official title:

The Effectiveness of Tranexamic Acid in Breast Esthetic Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945680
• Other study ID #: 17/2023
• Status: Recruiting
• Phase: Phase 4
• Start date: September 15, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, Ph.D.
• Phone: +48 608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss volume	Total blood volume loss will be calculated in milliliters.	24 hours after surgery
Secondary	HBG	Hemoglobin level measured before and 24 hours after surgery	24 hours after surgery
Secondary	D-dimer	D-dimer level measured before and 24 hours after surgery	24 hours after surgery
Secondary	Fibrinogen	Fibrinogen level measured before and 24 hours after surgery	24 hours after surgery