ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry

This study is currently recruiting participants.
Verified March 2014 by Goethe University
Sponsor:
Collaborator:
University Hospital Goettingen
Information provided by (Responsible Party):
Christian F. Weber, MD, Goethe University
ClinicalTrials.gov Identifier:
NCT01824147
First received: March 26, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

It is the aim of the present study to assess the prevalence of ASS-Nonresponse following cardiac surgery using the Multiple Electrode Aggregometry (MEA).


Condition
ASS-Nonresponse

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry

Resource links provided by NLM:


Further study details as provided by Goethe University:

Primary Outcome Measures:
  • ASPItest [ Time Frame: at day 3 and 5 after the first dose of aspirin following surgery ] [ Designated as safety issue: No ]
    Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)


Secondary Outcome Measures:
  • TRAPtest [ Time Frame: at day 3 and 5 after the first dose of aspirin following surgery ] [ Designated as safety issue: No ]
    Area under the aggregation curve in the Multiple Electrode Aggregometry following stimulation with thrombin receptor activating peptide 6

  • Platelet Count [ Time Frame: at day 3 and 5 after the first dose of aspirin following surgery ] [ Designated as safety issue: No ]
    Platelet count taken from the daily standard laboratory results.

  • Mortality [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study

  • Myocardial infarction [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.

  • Readmission to hospital [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Did a readmission to hospital due to cardiac or pulmonary reasons take place in the 12 month following enrollment into the study? Assessed by a telephonic follow up interview.


Other Outcome Measures:
  • Age [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Age of the patient in years at the time of enrollment

  • Height [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Height of the patient in centimeters at the time of enrollment

  • Weight [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Weight of the patient in kilograms at enrollment

  • Gender [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    Gender of the patient

  • LDL cholesterol [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    LDL cholesterol of the patient in mg/dl at enrollment

  • nicotine [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]

    Smoking habits of the patient will be documented at enrollment in the categories:

    • active smoker
    • non smoker

  • European system for cardiac operative risk evaluation (EuroSCORE) [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    EuroSCORE as assessed on admission will be documented.

  • Diabetes [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]

    Risk factor diabetes will be documented in the following categories at enrollment:

    • Diabetes Typ I
    • Diabetes Typ II without the need for insulin substitution
    • Diabetes Typ II with the need for insulin substitution

  • Surgical procedure [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    The surgical procedure performed will be documented.

  • phone number [ Time Frame: at the day of enrollment ] [ Designated as safety issue: No ]
    The phone will be documented for the 12 month follow up interview.


Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
CABG Patients
Patients undergoing surgery for coronary revascularization.

Detailed Description:

Up to now there are no data concerning the prevalence of ASS-Nonresponse following surgical coronary revascularization procedures as assessed with the Multiple Electrode Aggregometry. Results of the present observational study are needed to assess the prevalence of ASS-Nonresponse in order to perform a sample size analysis for a prospective interventional study in a second step.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients following cardiac surgery and a antiaggregatory therapy with aspirin

Criteria

Inclusion Criteria:

  • Patients older than 18 years after cardiac surgery
  • Antiaggregatory therapy with aspirin postoperatively

Exclusion Criteria:

  • known allergy to aspirin
  • need for an antiaggregatory therapy other than aspirin
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824147

Contacts
Contact: Saskia Wand, Dr. med. 0049 551 398826 saskia.wand@med.uni-goettingen.de
Contact: Christian F Weber, Dr. med. 0049 157 76400777 Christian.Weber@kgu.de

Locations
Germany
Goethe - University Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Christian F Weber, MD    +491726122166    christian.weber@kgu.de   
Contact: Kai Zacharowski, PhD, MD    +496963015998    kai.zacharowski@kgu.de   
Sub-Investigator: Patrick Meybohm, MD         
University Hospital Goettingen Not yet recruiting
Goettingen, Lower Saxony, Germany, 37073
Contact: Saskia Wand, Dr. med.    0049 551 398826    saskia.wand@med.uni-goettingen.de   
Contact: Michael Quintel, Professor    0049 551 398826    mquintel@med.uni-goettingen.de   
Principal Investigator: Saskia Wand, MD         
Sub-Investigator: Nils Kunze, MD         
Sub-Investigator: Anselm Braeuer, Professor         
Sub-Investigator: Ivo F Brandes, MD         
Sponsors and Collaborators
Goethe University
University Hospital Goettingen
Investigators
Principal Investigator: Christian F Weber, MD Cooperative Weichteilsarkom Study Group
  More Information

Publications:
Responsible Party: Christian F. Weber, MD, Dr.med. Dr.med. habil Christian F. Weber, Goethe University
ClinicalTrials.gov Identifier: NCT01824147     History of Changes
Other Study ID Numbers: 33/13
Study First Received: March 26, 2013
Last Updated: March 14, 2014
Health Authority: Germany: Regional Authority of Hessen, Darmstadt

Keywords provided by Goethe University:
ASS-Nonresponse
cardiac
surgery

ClinicalTrials.gov processed this record on April 15, 2014