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Evaluation of the new guideline for diagnosis and treatment catheter-related thrombosis in neonates on the neonatal intensive care unit


- candidate number15940
- NTR NumberNTR4336
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-dec-2013
- Secondary IDsWPTS study 1-NeoClot 
- Public TitleEvaluation of the new guideline for diagnosis and treatment catheter-related thrombosis in neonates on the neonatal intensive care unit
- Scientific TitleNEOnatal Central venous Line Observational study on Thrombosis
- ACRONYMNeoClot
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedThrombosis, Neonates, Central vein catheter
- Inclusion criteriaAll neonates and infants from 0 to 6 months of age on the neonatal intensive care unit with a catheter-related venous thrombosis
- Exclusion criteriaNo oral or written informed consent of the parents
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2014
- planned closingdate1-jan-2016
- Target number of participants100
- InterventionsPatients will be treated according to the new guideline: Diagnosis and Treatment of catheter-related thrombosis in neonates
- Primary outcomeComposite 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 outcomeSecondary 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.
- TimepointsThis observational study will last at least two years
- Trial web sitewww.neonatologiestudies.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES CH Ommen, van
- CONTACT for SCIENTIFIC QUERIES CH Ommen, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
National working group neonatal catheter-related thrombosis
- PublicationsN/A
- Brief summaryObservational 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
- Main changes (audit trail)
- RECORD24-dec-2013 - 2-feb-2014


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