E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients requiring diagnostic or interventional cardiac catheterisation (without Stent, device or catheter ablation) |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
|
E.2.2 | Secondary objectives of the trial |
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.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
high versus low dose of the IMP |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Visit 1 year after cardiac cathetherization |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |