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

NEOnatal Central venous Line Observational study on Thrombosis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26109

Enrollment

100

Registered

2013-12-24

Start date

2014-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-related thrombosis in neonates

Interventions

Patients will be treated according to the new guideline: Diagnosis and Treatment of catheter-related thrombosis in neonates

Eligibility

Inclusion criteria

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

Exclusion criteria: No oral or written informed consent of the parents

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactCH Ommen, van

c.vanommen@erasmusmc.nl010 7036691

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)