Skip to main content
OpenTrials
Completed

NCT Number: NCT01824147

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ASS-Nonresponse

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Goethe - University, Frankfurt am Main, Hesse, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ASPItest

    Time frame: at day 3 and 5 after the first dose of aspirin following surgery

    Area under the aggregation curve following stimulation with arachidonic acid in the Multiple Electrode Aggregometry (MEA)

Secondary outcomes

  1. TRAPtest

    Time frame: at day 3 and 5 after the first dose of aspirin following surgery

    Area under the aggregation curve in the Multiple Electrode Aggregometry following stimulation with thrombin receptor activating peptide 6

  2. Platelet Count

    Time frame: at day 3 and 5 after the first dose of aspirin following surgery

    Platelet count taken from the daily standard laboratory results.

  3. Mortality

    Time frame: 12 month

    Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study

  4. Myocardial infarction

    Time frame: 12 month

    Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.

  5. Readmission to hospital

    Time frame: 12 month

    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 outcomes

  1. Age

    Time frame: at the day of enrollment

    Age of the patient in years at the time of enrollment

  2. Height

    Time frame: at the day of enrollment

    Height of the patient in centimeters at the time of enrollment

  3. Weight

    Time frame: at the day of enrollment

    Weight of the patient in kilograms at enrollment

  4. Gender

    Time frame: at the day of enrollment

    Gender of the patient

  5. LDL cholesterol

    Time frame: at the day of enrollment

    LDL cholesterol of the patient in mg/dl at enrollment

  6. nicotine

    Time frame: at the day of enrollment

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

    • active smoker
    • non smoker

  7. European system for cardiac operative risk evaluation (EuroSCORE)

    Time frame: at the day of enrollment

    EuroSCORE as assessed on admission will be documented.

  8. Diabetes

    Time frame: at the day of enrollment

    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

  9. Surgical procedure

    Time frame: at the day of enrollment

    The surgical procedure performed will be documented.

  10. phone number

    Time frame: at the day of enrollment

    The phone will be documented for the 12 month follow up interview.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • University Hospital Goettingen

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2013
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.