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Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease

Primary Purpose

Lumbar Disc Degeneration, Surgical Procedure, Unspecified

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Observational
Sponsored by
Vinicius Magno da Rocha, MD, MSc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Degeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Observation

    Arm Description

    Clinical data analysis

    Outcomes

    Primary Outcome Measures

    Observation

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2015
    Last Updated
    August 30, 2021
    Sponsor
    Vinicius Magno da Rocha, MD, MSc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02496364
    Brief Title
    Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease
    Official Title
    Topical and Intravenous Use of Tranexamic Acid in Posterior Lumbar Interbody Fusion - A Prospective, Double-blind, Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Dismissal from the institution
    Study Start Date
    March 1, 2014 (Actual)
    Primary Completion Date
    February 1, 2015 (Actual)
    Study Completion Date
    February 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Vinicius Magno da Rocha, MD, MSc

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Degeneration, Surgical Procedure, Unspecified

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Observation
    Arm Type
    Other
    Arm Description
    Clinical data analysis
    Intervention Type
    Other
    Intervention Name(s)
    Observational
    Primary Outcome Measure Information:
    Title
    Observation
    Time Frame
    1

    10. Eligibility

    Accepts Healthy Volunteers
    No

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Topical and Intravenous Tranexamic Acid in Surgical Treatment of Lumbar Degenerative Disease

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