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Tranexamic Acid in Abdominoplasty.

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06086444
Collaborator
(none)
60
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: Tranexamic acid
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Tranexamic Acid in Abdominoplasty Plastic Surgery.
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood loss volume [24 hours after surgery]

      Total blood volume loss will be calculated in milliliters.

    Secondary Outcome Measures

    1. HBG [24 hours after surgery]

      Hemoglobin level measured before and 24 hours after surgery

    2. D-dimer [24 hours after surgery]

      D-dimer level measured before and 24 hours after surgery

    3. Fibrinogen [24 hours after surgery]

      Fibrinogen level measured before and 24 hours after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Poznan University of Medical Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Poznan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT06086444
    Other Study ID Numbers:
    • 16/2023
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemorrhage
    Tranexamic Acid

    Study Results

    No Results Posted as of Oct 17, 2023