Venous thromboembolism blood clot
Conditions
Interventions
Dose Nadroparine, Anti-Xa sample, efficacy and safety outcomes
Sponsors
Amsterdam UMC
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: All children 1 months to 18 years, admitted at a Children*s hospital, treated with therapeutic or prophylactic nadroparin treatment as part of standard clinical care. To avoid extra venepunctures, preferably children with a central venous catheter, arterial access or intravenous cannula will be included
Exclusion criteria
Exclusion criteria: • No informed consent • Major congenital malformations • Metabolic disorders • Previous cerebral bleeding • Children with any condition that, as judged by the investigator, would place the child at increased risk of harm if he/she participated in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic nadroparin administration: Primary endpoint: To establish evidence-based therapeutic dosing regimens of nadroparin for children in different age groups (2 months - 3 years, 4 - 11 years and >= 12 years) by means of objectification of the PK/PD of nadroparin during standard care. Prophylactic nadroparin administration: Primary endpoint: To establish evidence-based therapeutic dosing regimens of nadroparin for children in different age groups (2 months - 3 years, 4 - 11 years and >= 12 years) by means of objectification of the PK/PD of nadroparin during standard care. | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic nadroparin administration: Secondary endpoint: 1. The incidence of complete thrombus resolution in relation to anti Xa levels within 3 months after the start of nadroparin treatment 2. The incidence of major, clinically relevant and minor bleeding and its relation to anti Xa levels during treatment with nadroparin until 24 hours after termination of nadroparin Prophylactic nadroparin administration: Secondary endpoint: 1. The incidence of new or recurrent thrombosis in relation to anti Xa levels during treatment with nadroparin 2. The incidence of major, clinically relevant and minor bleeding and its relation to anti Xa levels during treatment with nadroparin until 24 hours after termination of nadroparin | — |
Countries
Netherlands
Contacts
Public ContactI.L.M. Klaassen
Amsterdam UMC
Outcome results
None listed