Investigated disease/health problem: Disorders of platelet function or reduced efficacy of platelet aggregation inhibition under acetylsalicylic acid (ASA) in the perioperative setting, particularly in cardiac and vascular surgical procedures performed with and without the use of a heart-lung machine (cardiopulmonary bypass, CPB).
Conditions
Interventions
Group 1: 320 patients who receive postoperative oral aspirin 100 mg/day after cardiac surgery with cardiopulmonary bypass are evaluated for platelet inhibition by aspirin after at least 5 days of trea
Sponsors
Uniklinik Ulm
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Cardiac surgery patients with planned coronary artery bypass grafting (CABG) and/or biological aortic valve replacement, with or without prior aspirin therapy, for whom postoperative aspirin therapy is planned. Vascular surgery patients with planned vascular procedures, with or without prior aspirin therapy, who have an indication for postoperative aspirin therapy.
Exclusion criteria
Exclusion criteria: -Known aspirin intolerance or allergy -Known aspirin non-response -Emergency surgery -Age 85 years -Patients with known anemia (Hb < 10 g/dL) and/or thrombocytopenia (< 80,000 Gpt/L) at the time of study inclusion -Cardiac surgery patients undergoing coronary artery bypass grafting (CABG) and/or biological aortic valve replacement in whom additional postoperative anticoagulation (e.g., NOACs or warfarin/Marcumar) is planned -Vascular surgery patients with a planned indication for additional anticoagulant therapy (e.g., NOACs or warfarin/Marcumar) after the vascular procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of aspirin response, measured by platelet function analysis (PFA-200), in comparison between the two treatment arms. During hospital admission and in the postoperative period—after at least five oral doses of aspirin (100 mg)—platelet function will be measured in blood using two laboratory tests (PFA-200 and Multiplate) in both cardiac surgery patients (with cardiopulmonary bypass) and vascular surgery patients (without cardiopulmonary bypass). The results will be compared between the two groups and over time. Over the course of the study, subgroups are expected depending on whether patients were already on long-term aspirin therapy preoperatively or not. In addition, the reliability of the blood tests will be assessed by measuring thromboxane B2 in urine, normalized to urinary creatinine. Thromboxane B2 is a metabolite of thromboxane A2, whose production should be inhibited by aspirin. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Absolute rate of patients without adequate early postoperative platelet inhibition (non-response) under aspirin therapy (100 mg/day), measured by PFA-200 platelet function analysis, compared with the literature. 2.Comparison with the results of an alternative platelet function test (Multiplate). 3.Correlation of 11-dehydro-thromboxane B2 (UTXB2), a urinary metabolite of thromboxane A2, with platelet function tests in blood. | — |
Countries
Germany
Contacts
Public ContactMurodjon Abdulkhaev
Uniklinik Ulm
Outcome results
None listed