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Tranexamic Acid in Abdominoplasty.

Primary Purpose

Abdominal Wall Defect, Hemorrhage, Bleeding

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
Tranexamic acid
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Wall Defect

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Tranexamic acid

    Arm Description

    Normal saline for intravenous administration.

    Tranexamic Acid for intravenous administration.

    Outcomes

    Primary Outcome Measures

    Blood loss volume
    Total blood volume loss will be calculated in milliliters.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 11, 2023
    Last Updated
    October 11, 2023
    Sponsor
    Poznan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06086444
    Brief Title
    Tranexamic Acid in Abdominoplasty.
    Official Title
    The Effectiveness of Tranexamic Acid in Abdominoplasty Plastic Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Poznan University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Wall Defect, Hemorrhage, Bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline for intravenous administration.
    Arm Title
    Tranexamic acid
    Arm Type
    Active Comparator
    Arm Description
    Tranexamic Acid for intravenous administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    0.9% sodium chloride
    Intervention Description
    100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Other Intervention Name(s)
    TXA
    Intervention Description
    Tranexamic Acid (10mg/kg), diluted in 100 ccs of normal saline. Administered intravenously at least 10 minutes before skin incision.
    Primary Outcome Measure Information:
    Title
    Blood loss volume
    Description
    Total blood volume loss will be calculated in milliliters.
    Time Frame
    24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    HBG
    Description
    Hemoglobin level measured before and 24 hours after surgery
    Time Frame
    24 hours after surgery
    Title
    D-dimer
    Description
    D-dimer level measured before and 24 hours after surgery
    Time Frame
    24 hours after surgery
    Title
    Fibrinogen
    Description
    Fibrinogen level measured before and 24 hours after surgery
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Małgorzata Domagalska, Ph.D.
    Phone
    +48 608762068
    Email
    m.domagalska@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Małgorzata Domagalska, Ph.D.
    Organizational Affiliation
    Poznań University of Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Tranexamic Acid in Abdominoplasty.

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