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

Completed

• Conditions: ASS-Nonresponse

• Registration Number: NCT01824147
• Lead Sponsor: Goethe University

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.

Study Timeline

• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-31
• Study First Posted: 2013-04-04
• Study Start: 2013-08
• Primary Completion: 2015-03
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (2)

Goethe - University; 🇩🇪 Frankfurt, Hessen, Germany

University Hospital Goettingen; 🇩🇪 Goettingen, Lower Saxony, Germany