Tranexamic Acid in Abdominoplasty.

The Effectiveness of Tranexamic Acid in Abdominoplasty Plastic Surgery.

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhage; Bleeding; Abdominal Wall Defect
• 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 abdominoplasty. The purpose is to quantify blood loss during plastic surgery with and without TXA.

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

Contacts and Locations

• Study Contact: Name: Małgorzata Domagalska, Ph.D.; Phone Number: +48 608762068; Email: m.domagalska@icloud.com

Study Locations

• Poland
  • Poznań
    • Poznan, Poznań, Poland, 61-701
      • Recruiting
      • Poznan University of Medical Sciences
      • Contact: Malgorzata Domagalska, Ph.D.; Phone Number: 608762068; Email: m.domagalska@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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: Principal Investigator: Małgorzata Domagalska, Ph.D., Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 16/2023

Drug and device information, study documents

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