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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014