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Bleeding in Patients Undergoing CABG (Coronary Artery Bypass Graft) During Dual Antiplatelet Therapy

Sponsor
Medical University of Graz (Other)
Overall Status
Terminated
CT.gov ID
NCT02030548
Collaborator
(none)
144
Enrollment
1
Location
36
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    144 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Bleeding in Patients Undergoing Urgent CABG During Dual Antiplatelet Therapy Including the New P2Y12 Receptor Inhibitors Prasugrel and Ticagrelor
    Study Start Date :
    Nov 1, 2013
    Actual Primary Completion Date :
    Nov 1, 2016
    Actual Study Completion Date :
    Nov 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    acute CABG

    patients undergoing acute CABG with or without valve replacement during dual antiplatelet therapy

    Outcome Measures

    Primary Outcome Measures

    1. calculated blood loss [until postoperative day 5]

    Secondary Outcome Measures

    1. mortality [from index surgery until one year after index surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    consecutive patients undergoing acute CABG with or without valve replacement within 7 days after last intake of dual antiplatelet therapy

    Exclusion Criteria:

    concomitant oral anticoagulants dialysis surgery employing hypothermic cardiac arrest

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Anesthesiology and Intensive Care Medicine Graz Styria Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    • Principal Investigator: Elisabeth Mahla, MD, Dept. of Anesthesiology and Intensive Care Medicine, MUG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT02030548
    Other Study ID Numbers:
    • NIS003684
    First Posted:
    Jan 8, 2014
    Last Update Posted:
    Jun 6, 2019
    Last Verified:
    Jun 1, 2019
    Keywords provided by Medical University of Graz
    CABG
    dual antiplatelet therapy
    aspirin
    clopidogrel
    prasugrel
    ticagrelor
    Additional relevant MeSH terms:
    Acute Coronary Syndrome

    Study Results

    No Results Posted as of Jun 6, 2019