Therapeutic nadroparin administration:Primary objective: To develop evidence-based dosing regimens of nadroparin for extremely premature, premature and term neonates by means of the objectification of the PK/PD of nadroparin.Secondary objective: 1)…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Therapeutic nadroparin administration:
To establish evidence-based therapeutic dosing regimens of nadroparin for
extremely premature, premature and term neonates by means of objectification of
the PK/PD of nadroparin during standard care.
Prophylactic nadroparin administration:
To establish evidence-based therapeutic dosing regimens of nadroparin for
premature and term neonates by means of objectification of the PK/PD of
nadroparin during standard care.
premature and term neonates
Secondary outcome
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
Background summary
The incidence of venous thrombosis is rising rapidly in neonates.[1,2] This
rise is the result of improved neonatal care over the past 20 years resulting
in an increase in the survival of (extremely) premature and critically ill
infants. When a venous thrombus occurs there is an indication for therapeutic
anticoagulant treatment (anti Xa levels 0.5-1.0 IU/mL). Inhibition of the
coagulation system gives the opportunity to resolve the clot. If neonates are
at high risk for venous thrombosis preventive measures can be taken by
prophylactic anticoagulant treatment (anti-Xa levels 0.1-0.4 IU/mL). This
inhibits the coagulation system in a lesser way compared to therapeutic
anticoagulant treatment and prevents formation of a thrombus.
In the Netherlands each year 250 neonates receive off-label therapeutic and
prophylactic nadroparin treatment, without any information on the
pharmacokinetics/-dynamics (PK/PD) and therefore optimal and safe dosage
regimen. As a result, these neonates are prone to suboptimal treatment with a
risk for thrombosis, a lack of thrombus resolution or major bleeding.
Therefore we designed an observational study during standard care to objectify
the PK/PD in neonates.
Study objective
Therapeutic nadroparin administration:
Primary objective:
To develop evidence-based dosing regimens of nadroparin for extremely
premature, premature and term neonates by means of the objectification of the
PK/PD of nadroparin.
Secondary objective:
1) Investigate the relation between anti Xa levels and thrombus resolution
within 3 months after the start of nadroparin treatment
Investigate the relation between anti Xa levels and bleeding during treatment
with nadroparin until 24 hours after termination of nadroparin
Prophylactic nadroparin administration:
Primary objective:
To develop evidence-based dosing regimens of nadroparin for premature and term
neonates by means of the objectification of the PK/PD of nadroparin.
Secondary objective:
1) Investigate the relation between anti Xa levels and new or recurrent
thrombosis during treatment with nadroparin
Study design
A national observational prospective study, conducted in 6 Neonatal Intensive
Care Units/ Children*s Hospitals in the Netherlands.
Study burden and risks
As mentioned above, each year 250 neonates receive off label nadroparin
treatment without any information on PK/PD and therefore optimal and safe
therapeutic or prophylactic dosage regimen. Despite this off label treatment,
dosage recommendations have been provided. As a result, these neonates are
prone to suboptimal treatment with a risk of a new thrombosis, a lack of
thrombus resolution, or major bleeding. This bleeding has an impact on the
morbidity and survival of neonates Therefore we will perform an observational
study during standard care to objectify the PK/PD in neonates. With the
development of evidence-based therapeutic dosing regimens for extremely
premature, premature and term neonates, and evidence-based prophylactic dosing
regimens for premature and term neonates for nadroparin we can ensure these
vulnerable neonates an effective treatment without toxicity, and therefore less
complications. A possible risk is reducing the circulating blood volume of
neonates by taking blood. Therefore we minimized the volume blood samples (5 mL
in total per neonate). To avoid the burden of venepunctures we aim to include
mainly neonates with central venous or arterial access and combine blood
samples with standard blood samples.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.
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 |
|---|---|
| CCMO | NL84834.018.24 |