No registrations found.
ID
Source
Brief title
Health condition
Catheter-related thrombosis in neonates
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite efficacy endpoint consists of incidence of recurrent VTE and death as result of VTE, after start of anticoagulant therapy + 3 days.
Primary safety endpoint is the frequency of major bleeding during anticoagulation treatment.
Secondary outcome
Secondary efficacy endpoints consists of the individual components of the primary efficacy endpoint.
Secondary safety endpoints are the frequency of clinically relevant non-major bleeding and minor bleeding occurring during anticoagulation treatment.
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.
Background summary
Observational study to investigate the efficacy and safety of a new national guideline for diagnosis and treatment of catheter-related thrombosis in neonates on the neonatal intensive care unit
Study objective
N/A
Study design
This observational study will last at least two years
Intervention
Patients will be treated according to the new guideline: Diagnosis and Treatment of catheter-related thrombosis in neonates
ErasmusMC Sophia Children's Hospital
Rotterdam 3015CN
The Netherlands
010 7036691
c.vanommen@erasmusmc.nl
ErasmusMC Sophia Children's Hospital
Rotterdam 3015CN
The Netherlands
010 7036691
c.vanommen@erasmusmc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4186 |
NTR-old | NTR4336 |
Other | : WPTS study 1-NeoClot |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |