Tranexamic Acid in Abdominoplasty.

Phase 4

Recruiting

• Conditions: Abdominal Wall Defect; Hemorrhage; Bleeding
• Interventions: Drug: Placebo; Drug: Tranexamic acid

• Registration Number: NCT06086444
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

The investigators prepared a novel tranexamic acid (TXA) study designed to estimate the quantity of blood loss in patients undergoing abdominoplasty 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 patients undergoing abdominoplasty surgery.

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 abdominoplasty. The purpose is to quantify blood loss during plastic surgery with and without TXA.

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study Start: 2023-10-17
• Study First Posted: 2023-10-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Scheduled abdominoplasty
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline for intravenous administration.
Tranexamic acid	Tranexamic acid	Tranexamic Acid for intravenous administration.

Primary Outcome Measures

Name	Time	Method
Blood loss volume	24 hours after surgery	Total blood volume loss will be calculated in milliliters.

Secondary Outcome Measures

Name	Time	Method
HBG	24 hours after surgery	Hemoglobin level measured before and 24 hours after surgery
D-dimer	24 hours after surgery	D-dimer level measured before and 24 hours after surgery
Fibrinogen	24 hours after surgery	Fibrinogen level measured before and 24 hours after surgery

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poznań, Poland