RANDOMIZED CONTROLLED TRIAL COMPARING TWO HEPARINIZATION PROTOCOLS FOR PROPHYLAXIS OF SHORT- AND LONG-TERM THROMBOTIC COMPLICATIONS OF PEDIATRIC CARDIAC CATHETERIZATION The HEARTCAT – Study (HEparin Anticoagulation Randomised Trial for Cardiac Catheterization) - HEARTCAT

• Conditions: Patients requiring diagnostic or interventional cardiac catheterisation (without Stent, device or catheter ablation)

• Registration Number: EUCTR2005-004150-27-AT
• Lead Sponsor: niversitätsklinik für Kinder- und Jugendheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-12
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified