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Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

Primary Purpose

Arthritis Knee, Spine Fusion, Prostate Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TXA
TEG6
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Knee focused on measuring bleeding, viscoelastic test, tranexamic acid, transfusion, thromboembolism, fibrinolysis, seizure

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria patients undergoing following surgery spinal fusion surgery with more than 2 levels total hip arthroplasty total knee arthroplasty open prostatectomy hepatectomy Exclusion Criteria: pregnancy refusal of allogenic blood transfusion taking thrombin history of thromboembolic and familial hypercoagulability disease recent history of myocardial infarction or ischemic cerebral infarction (within 90 days) hypersensitive to TXA histroy of convulsion or epilepsy taking hemodialysis history of Heparin-induced thrombocytopenia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    TXA empirical

    TXA TEG6-triggered

    TXA TEG6-non-triggered

    Arm Description

    Empirical Tranexamic acid (TXA) administration after the anesthesia induction

    When LY30> 3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered

    When LY30 ≦ 3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered

    Outcomes

    Primary Outcome Measures

    CRT maximal amplitude
    maximal amplitude of CRT test

    Secondary Outcome Measures

    CK reaction time
    value of r-time of CK test
    CK alpha angle
    value of alpha-angle of CK test
    CRT maximal lysis
    value of maximal lysis of CRT test
    CFF maximal amplitude
    value of maximal amplitude of CFF test
    Hemoglobin
    serum hemoglobin value
    packed RBC
    number of unit, transfused packed RBC
    fresh frozen plasma
    number of unit, transfused fresh frozen plasma
    cryoprecipitate
    number of unit, transfused cryoprecipitate
    platelet
    number of unit, transfused platelet (apheresis) or platelet concentrate
    seizure
    incidence of postoperative seizure
    thromboembolism
    incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
    postoperative bleeding
    amount of bleeding from surgical drain
    re-operation
    incidence of re-operation due to postoperative bleeding

    Full Information

    First Posted
    July 7, 2023
    Last Updated
    October 5, 2023
    Sponsor
    Konkuk University Medical Center
    Collaborators
    Korea Health Industry Development Institute, Asan Medical Center, Soon Chun Hyang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05957822
    Brief Title
    Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery
    Official Title
    Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac 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
    September 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Konkuk University Medical Center
    Collaborators
    Korea Health Industry Development Institute, Asan Medical Center, Soon Chun Hyang University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.
    Detailed Description
    The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis Knee, Spine Fusion, Prostate Cancer, Arthritis of Hip, Hepatic Cancer
    Keywords
    bleeding, viscoelastic test, tranexamic acid, transfusion, thromboembolism, fibrinolysis, seizure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized prospective multicenter non-inferior
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    148 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TXA empirical
    Arm Type
    Active Comparator
    Arm Description
    Empirical Tranexamic acid (TXA) administration after the anesthesia induction
    Arm Title
    TXA TEG6-triggered
    Arm Type
    Experimental
    Arm Description
    When LY30> 3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered
    Arm Title
    TXA TEG6-non-triggered
    Arm Type
    Experimental
    Arm Description
    When LY30 ≦ 3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered
    Intervention Type
    Drug
    Intervention Name(s)
    TXA
    Other Intervention Name(s)
    TXA administration
    Intervention Description
    Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    TEG6
    Other Intervention Name(s)
    thromboelastography 6
    Intervention Description
    performing thromboelastography (TEG6)
    Primary Outcome Measure Information:
    Title
    CRT maximal amplitude
    Description
    maximal amplitude of CRT test
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    CK reaction time
    Description
    value of r-time of CK test
    Time Frame
    24 hours
    Title
    CK alpha angle
    Description
    value of alpha-angle of CK test
    Time Frame
    24 hours
    Title
    CRT maximal lysis
    Description
    value of maximal lysis of CRT test
    Time Frame
    24 hours
    Title
    CFF maximal amplitude
    Description
    value of maximal amplitude of CFF test
    Time Frame
    24 hours
    Title
    Hemoglobin
    Description
    serum hemoglobin value
    Time Frame
    24 hours
    Title
    packed RBC
    Description
    number of unit, transfused packed RBC
    Time Frame
    6 hours
    Title
    fresh frozen plasma
    Description
    number of unit, transfused fresh frozen plasma
    Time Frame
    6 hours
    Title
    cryoprecipitate
    Description
    number of unit, transfused cryoprecipitate
    Time Frame
    6 hours
    Title
    platelet
    Description
    number of unit, transfused platelet (apheresis) or platelet concentrate
    Time Frame
    6 hours
    Title
    seizure
    Description
    incidence of postoperative seizure
    Time Frame
    48 hours
    Title
    thromboembolism
    Description
    incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
    Time Frame
    48 hours
    Title
    postoperative bleeding
    Description
    amount of bleeding from surgical drain
    Time Frame
    48 hours
    Title
    re-operation
    Description
    incidence of re-operation due to postoperative bleeding
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria patients undergoing following surgery spinal fusion surgery with more than 2 levels total hip arthroplasty total knee arthroplasty open prostatectomy hepatectomy Exclusion Criteria: pregnancy refusal of allogenic blood transfusion taking thrombin history of thromboembolic and familial hypercoagulability disease recent history of myocardial infarction or ischemic cerebral infarction (within 90 days) hypersensitive to TXA histroy of convulsion or epilepsy taking hemodialysis history of Heparin-induced thrombocytopenia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Soi Lee
    Phone
    +82 10 4418 9288
    Email
    soileekku@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tae-Yop Kim, MD, PhD
    Organizational Affiliation
    Konkuk University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

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