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Goal-orientated Therapy of Perioperative Disturbance in Hemostasis in Cardiac Surgery

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT00516126
Collaborator
(none)
200
Enrollment
1
Location
30
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of this study is to investigate whether patients preoperatively treated with acetylsalicylic acid and/or clopidogrel have fewer perioperative bleeding and lower amounts of blood substitution when managed by ROTEM (whole blood coagulation analyzer) and MULTIPLATE (thrombocyte function analyzer).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Goal-orientated Therapy of Perioperative Disturbance in Hemostasis With MULTIPLATE and ROTEM in Cardiac Surgery Patients Under Platelets Inhibitors
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Point-of-Care managed

    This arm includes all patients in which the hemostatic therapy is guided by POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry)
    Conventional hemostasis lab managed

    This arm includes all patients in which the hemostatic therapy is guided by conventional hemostasis laboratory data e.g. INR, aPTT, fibrinogen concentration, platelet count but no POC devices e.g. MULTIPLATE (a platelet function analyzer) or ROTEM (thromboelastometry)

    Outcome Measures

    Primary Outcome Measures

    1. Perioperative blood loss [24 hours]

    Secondary Outcome Measures

    1. perioperative substitution with erythrocyte concentrates, thrombocyte concentrates or fresh frozen plasma [24 hours and 7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • written consent
    Exclusion Criteria:
    • no written consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel Basel CH Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Study Director: Miodrag Filipovic, PhD, MD, Department of Anesthesia, University Hospital Basel, CH-4031 Basel, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Bolliger, PD Dr. Daniel Bolliger, University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT00516126
    Other Study ID Numbers:
    • 194/06
    First Posted:
    Aug 14, 2007
    Last Update Posted:
    Jan 11, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Daniel Bolliger, PD Dr. Daniel Bolliger, University Hospital, Basel, Switzerland
    hemostasis monitoring
    perioperative blood loss
    Additional relevant MeSH terms:
    Hemostatic Disorders
    Blood Coagulation Disorders

    Study Results

    No Results Posted as of Jan 11, 2013