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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01824147

Enrollment

400

Registered

2013-04-04

Start date

2013-08-31

Completion date

2015-08-31

Last updated

2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASS-Nonresponse

Keywords

ASS-Nonresponse, cardiac, surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ASPItest	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

Measure	Time frame	Description
TRAPtest	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
Platelet Count	at day 3 and 5 after the first dose of aspirin following surgery	Platelet count taken from the daily standard laboratory results.
Mortality	12 month	Mortality will be assessed by a telephonic follow up interview 12 month after enrollment into the study
Myocardial infarction	12 month	Occurrence of a myocardial infarction during the 12 month following surgery assessed in a telephonic follow up interview.
Readmission to hospital	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

Measure	Time frame	Description
European system for cardiac operative risk evaluation (EuroSCORE)	at the day of enrollment	EuroSCORE as assessed on admission will be documented.
Diabetes	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
Age	at the day of enrollment	Age of the patient in years at the time of enrollment
phone number	at the day of enrollment	The phone will be documented for the 12 month follow up interview.
Surgical procedure	at the day of enrollment	The surgical procedure performed will be documented.
Height	at the day of enrollment	Height of the patient in centimeters at the time of enrollment
Weight	at the day of enrollment	Weight of the patient in kilograms at enrollment
Gender	at the day of enrollment	Gender of the patient
LDL cholesterol	at the day of enrollment	LDL cholesterol of the patient in mg/dl at enrollment
nicotine	at the day of enrollment	Smoking habits of the patient will be documented at enrollment in the categories: * active smoker * non smoker

Countries

Germany

Outcome results