Evaluation of the new guideline for diagnosis and treatment catheter-related thrombosis in neonates on the neonatal intensive care unit
- Conditions
- Catheter-related thrombosis in neonates
- Registration Number
- NL-OMON26109
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
All neonates and infants from 0 to 6 months of age on the neonatal intensive care unit with a catheter-related venous thrombosis
Exclusion Criteria
No oral or written informed consent of the parents
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite efficacy endpoint consists of incidence of recurrent VTE and death as result of VTE, after start of anticoagulant therapy + 3 days.<br>Primary safety endpoint is the frequency of major bleeding during anticoagulation treatment.
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints consists of the individual components of the primary efficacy endpoint.<br>Secondary safety endpoints are the frequency of clinically relevant non-major bleeding and minor bleeding occurring during anticoagulation treatment.<br><br /><br /><br>Additional endpoints are the frequency of risk factors for thrombosis, the frequency of protocol violations and the frequency of long-term consequences of thrombosis, i.e. post thrombotic syndrome and the presence of residual thrombosis.