Safety and efficacy of nadroparin in neonates: an observational study.
- Conditions
- blood clothThrombosis1006447710028920
- Registration Number
- NL-OMON56793
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
Neonates already receiving therapeutic or prophylactic nadroparin dosage as
part of their treatment.
Exclusion Criteria
•No informed consent
•Major congenital malformations
•Metabolic disorders
•Previous cerebral bleeding
•Neonates with any condition that, as judged by the investigator, would place
the neonate at increased risk of harm if he/she participated in the study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Therapeutic nadroparin administration:<br /><br>To establish evidence-based therapeutic dosing regimens of nadroparin for<br /><br>extremely premature, premature and term neonates by means of objectification of<br /><br>the PK/PD of nadroparin during standard care.<br /><br><br /><br><br /><br>Prophylactic nadroparin administration:<br /><br>To establish evidence-based therapeutic dosing regimens of nadroparin for<br /><br>premature and term neonates by means of objectification of the PK/PD of<br /><br>nadroparin during standard care.<br /><br>premature and term neonates</p><br>
- Secondary Outcome Measures
Name Time Method <p>Therapeutic nadroparin administration:<br /><br>Secondary endpoint:<br /><br>1. The incidence of complete thrombus resolution in relation to anti Xa levels<br /><br>within 3 months after the start of nadroparin treatment<br /><br>2. The incidence of major, clinically relevant and minor bleeding and its<br /><br>relation to anti Xa levels during treatment with nadroparin until 24 hours<br /><br>after termination of nadroparin<br /><br><br /><br><br /><br><br /><br>Prophylactic nadroparin administration:<br /><br>Secondary endpoint:<br /><br>1. The incidence of new or recurrent thrombosis in relation to anti Xa levels<br /><br>during treatment with nadroparin<br /><br>2. The incidence of major, clinically relevant and minor bleeding and its<br /><br>relation to anti Xa levels during treatment with nadroparin until 24 hours<br /><br>after termination of nadroparin</p><br>