Patients requiring diagnostic or interventional cardiac catheterisation (without Stent, device or catheter ablation)
Conditions
Interventions
Trade Name: Heparin "Immuno"
Product Name: Heparin
Pharmaceutical Form: Anticoagulant and preservative solution for blood
Sponsors
Universitätsklinik für Kinder- und Jugendheilkunde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population will consist of consecutive pediatric patients, 0-18 years, requiring diagnostic or interventional cardiac catheterisation at the Division of Pediatric cardiology, Department of Pediatric and Adolescent Medicine, Medical University of Vienna. Patients will be invited to participate in the study at time of admission to cardiac catheter laboratory. Written informed consent will be obtained from parents/ guardians and patients of appropriate age. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: Exclusion criteria will be interventional cardiac catheterisation with stent or device application, electrophysical examination and catheter ablation, and preexisting anticoagulation, as for these subgroups of i cardiac catheterization randomization to a heparinization protocol is considered inappropriate. Excluded patients will form a subgroup of the study to assess cardiac catheterization-related vascular complications, undergoing the same outcome assessment investigations and the same assessment of baseline variables, prognostic factors, and congenital risk factors, but receiving individual heparin prophylaxis (standard of care heparin) during cardiac catheterisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the combination of bolus and continuous infusion of heparin (high dose heparinization) can decrease the incidence of cardiac catheterization-related thrombosis in children compared to a bolus of heparin alone (low dose heparinization).;Secondary Objective: 2. To objectively determine the incidence of short-term (pulse loss, decreased extremity blood –flow, arterial thrombotic occlusion, deep venous thrombosis) and long-term vascular complications (reduced limb growth, post-thrombotic syndrome) of cardiac catheterization in children. 3. To determine the sensitivity of clinical diagnosis compared to Doppler/ Duplex sonography for cardiac catheterization-related thrombosis in children. 4. To study the association of various acquired risk factors and prothrombotic conditions with the incidence of cardiac catheterization-related thrombosis. 5. To assess the value of various laboratory assays for monitoring of heparin during cardiac catheterization. ;Primary end point(s): Primary study outcome will be short term vascular occlusion/ thrombosis of peripheral vessels of the lower extremity diagnosed by duplex sonography. | — |
Countries
Austria
Outcome results
None listed