children after interventional cardiac catheterization.
Conditions
Interventions
Trade Name: Aspirin
Product Name: Aspirin
Product Code: B01
Pharmaceutical Form: Tablet
Sponsors
Medical University Vienna- Dept. of Pediatric Hemostaselology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population is a consecutive cohort of children undergoing interventional cardiac catheterization at the University childrenâ??s Hospital of Zurich with dilatation of single valve stenosis, stent implantation or dilatation of isolated pulmonary artery or aortic stenosis, or occlusion of atrial or ventricular septal defects. Based upon preliminary information, the cohort will include an approximate number of 50 children per year. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Children will be excluded from the study if they have one of the following conditions: dysmorphic syndrome that can interfere with platelet function such as Trisomie 21 and TAR syndrome, known congenital metabolic or hemorrhagic disorders, known anemia (hemoglobin < 100 g/l) and thrombocytopenia (platelet < 150 G/l), known aspirin-allergy, intake of other medications interfering with platelet function, and parents unwilling to consent to the study. Patients non-compliant to the prescribed intake of aspirin during the week before the laboratory studies at time points 3 and 6 months, respectively. It is up to the primary investigators to exclude other patients that are non-compliant to the aspirin intake at other time points of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the frequency of bleeding complications during ASA treatment. To determine the prevalence of aspirin resistance in children after interventional cardiac catheterization.;Secondary Objective: To further study children, who have not been included in the study due to abnormal initial coagulation studies and to correlate their abnormal findings with a history of bleeding symptoms.To investigate whether children with aspirin resistance would benefit from an increase of the aspirin doseTo determine whether a correlation exists between post-interventional findings including venous or arterial thrombotic events, neurological symptoms, and aspirin resistance in children after interventional cardiac catheterizationTo determine whether the prevalence of aspirin resistance varies with age. To determine whether the platelet function analyzer PFA-100, platelet aggregometry and the Shear viscometer are reliable laboratory test for the diagnosis of aspirin resistance in children, and whether results correlate with each other.;Primary end point(s): prevalence of aspirin resistance in children after interventional cardiac catheterization. | — |
Countries
Austria
Outcome results
None listed