Tranexamic Acid in Abdominoplasty.

Last updated: January 22, 2024
Sponsor: Poznan University of Medical Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

Hemorrhage

Treatment

Placebo

Tranexamic acid

Clinical Study ID

NCT06086444
16/2023
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Scheduled abdominoplasty
  • ASA 1 or 2
  • age >18 and <75 years

Exclusion

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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
October 17, 2023
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Poznan University of Medical Sciences

    Poznan, Poznań 61-701
    Poland

    Active - Recruiting

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