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Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty

Primary Purpose

Degenerative Arthritis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Degenerative Arthritis focused on measuring Tranexamic acid

Eligibility Criteria

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

Inclusion Criteria:

  • patients with diagnosis of primary osteoarthritis

Exclusion Criteria:

  • patients with diagnoses other than primary OA
  • patients on anticoagulation therapy
  • patient with chronic renal failure
  • patient with CVA Hx
  • Patient with seizure Hx
  • Patient with severe CHF
  • Patient with acquired or congenital coagulopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Only Intravenous Group

    Intravenous + Topical 1g Group

    Intravenous + Topical 2g Group

    No Intravenous, Only Topical 2g Group

    Arm Description

    Only Intravenous Injection During Operation, 10mg/kr

    Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g

    Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g

    Only Topical Injection 2g

    Outcomes

    Primary Outcome Measures

    Change in Hemoglobin
    Blood loss reduce

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2014
    Last Updated
    November 7, 2014
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02286973
    Brief Title
    Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty
    Official Title
    Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    April 2015 (Anticipated)
    Study Completion Date
    June 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA. To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Arthritis
    Keywords
    Tranexamic acid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    264 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Only Intravenous Group
    Arm Type
    Active Comparator
    Arm Description
    Only Intravenous Injection During Operation, 10mg/kr
    Arm Title
    Intravenous + Topical 1g Group
    Arm Type
    Active Comparator
    Arm Description
    Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g
    Arm Title
    Intravenous + Topical 2g Group
    Arm Type
    Active Comparator
    Arm Description
    Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g
    Arm Title
    No Intravenous, Only Topical 2g Group
    Arm Type
    Active Comparator
    Arm Description
    Only Topical Injection 2g
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Primary Outcome Measure Information:
    Title
    Change in Hemoglobin
    Description
    Blood loss reduce
    Time Frame
    baseline and 5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with diagnosis of primary osteoarthritis Exclusion Criteria: patients with diagnoses other than primary OA patients on anticoagulation therapy patient with chronic renal failure patient with CVA Hx Patient with seizure Hx Patient with severe CHF Patient with acquired or congenital coagulopathy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    TaeKyun Kim, MD,PhD
    Phone
    082-031-787-3355
    Email
    osktk@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sungyup Lee, MD
    Phone
    082-031-787-6480
    Email
    oslsy1204@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty

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