Clinical trial NCT01824147: ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry
Official title: ASS-Nonresponse Following Cardiac Surgery as Assessed With Multiple Electrode Aggregometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ASS-Nonresponse
Keywords: ASS-Nonresponse
cardiac
surgery
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: University Hospital Goettingen
First posted: 2013-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients following cardiac surgery and a antiaggregatory therapy with aspirin

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

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 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

Primary outcomes:
measure: ASPItest
timeFrame: at day 3 and 5 after the first dose of aspirin following surgery
Secondary outcomes:
measure: TRAPtest
timeFrame: at day 3 and 5 after the first dose of aspirin following surgery
measure: Platelet Count
timeFrame: at day 3 and 5 after the first dose of aspirin following surgery
measure: Mortality
timeFrame: 12 month
measure: Myocardial infarction
timeFrame: 12 month
measure: Readmission to hospital
timeFrame: 12 month
Other outcomes:
measure: Age
timeFrame: at the day of enrollment
measure: Height
timeFrame: at the day of enrollment
measure: Weight
timeFrame: at the day of enrollment
measure: Gender
timeFrame: at the day of enrollment
measure: LDL cholesterol
timeFrame: at the day of enrollment
measure: nicotine
timeFrame: at the day of enrollment
measure: European system for cardiac operative risk evaluation (EuroSCORE)
timeFrame: at the day of enrollment
measure: Diabetes
timeFrame: at the day of enrollment
measure: Surgical procedure
timeFrame: at the day of enrollment
measure: phone number
timeFrame: at the day of enrollment
Locations:
city: Frankfurt
country: Germany
facility: Goethe - University
state: Hessen
city: Goettingen
country: Germany
facility: University Hospital Goettingen
state: Lower Saxony
Study officials:
affiliation: Goethe University Frankfurt
name: Christian F Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collet JP, Cuisset T, Range G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.