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Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00778492
Collaborator
(none)
60
Enrollment
1
Location
7
Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study Design:

    Prospective observational study with blinded assessment of study endpoint variables. Collection of information concerning study endpoints will be performed by the investigator blinded to the results of preoperative testing of platelet function. The information will be collected from 60 patients undergoing cardiac surgery in the Department of Cardiac Surgery of Sheba Medical Center.

    Study endpoints

    1. Primary endpoint- resternotomy for bleeding after the surgery.

    2. Secondary endpoints- chest tube output during first 24 hours after the surgery; consumption of blood products during first 3 postoperative days.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
    Study Start Date :
    May 1, 2008
    Anticipated Primary Completion Date :
    Oct 1, 2008
    Anticipated Study Completion Date :
    Dec 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    No Treatment

    Patients with the history of ingestion of aspirin and/or ADP receptor antagonist (clopidogrel or ticlopidine) for at least 7 days prior the surgery. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass on elective and urgent basis.

    Outcome Measures

    Primary Outcome Measures

    1. Re-sternotomy d/t Bleeding [Hospitalization Period]

    Secondary Outcome Measures

    1. Chest tube output during first 24 hours after the surgery [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing cardiac surgery with the history of aspirin and/or ADP receptor antagonist for at least 7 days prior the surgery
    Exclusion Criteria:

    • Emergent surgery

    • Heart transplant surgery

    • Implantation of ventricular assist devices

    • Enrollment into conflicting study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Tel Hashomer Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Sergey Preisman, MD, Sheba Medical Center
    • Study Director: Alexander Kogan, MD, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00778492
    Other Study ID Numbers:
    • SHEBA-08-5119-SP-CTIL
    First Posted:
    Oct 23, 2008
    Last Update Posted:
    Oct 23, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    Thrombelastogram
    Microvascular bleeding
    antiplatelet medication
    cardiac surgery
    consumption of blood products
    preoperative platelet mapping derived from modified TEG
    postoperative bleeding
    Additional relevant MeSH terms:
    Hemorrhage

    Study Results

    No Results Posted as of Oct 23, 2008