The objective of the study is to evaluate in a prospective setting the effect of body weight on anti-Xa levels in the blood after administration of prophylactic nadroparin 2850 IE to patients admitted to the hospital. Second, we want to see what the…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determinants:
1. Body weight will be expressed as lean body weight (measured with an
impedance-measurement), BMI and the absolute body weight in kilograms. This
will be analyzed continously as well as in categories of <50kg; 50-100kg; and
>100kg.
2. Kidney function will be expressed as the creatinine clearance in
ml/min/1.73m2 calculated with the CKD-EPI en Cockcroft and Gault formulas.
Primaire outcome:
Anti-Xa levels 4 hours after administration of a standard prophylactic dose of
nadroparin 2850 IE .
Secondary outcome
1. Anti-Xa levels <0.2 IU/ml or >0.5 IU/ml (=outside prophylactic range).
2. Anti-Xa levels 4 days after administration of the standard nadroparin dose
of 2850 IE in 4 subgroups i.e. bodyweight<50kg; >150kg; creatinine clearance
30-60 ml/min/1.73m2; and <30 ml/min/1.73m2.
3. Any occurence of deep venous thrombosis, pumonary embolism or bleeding
within 8 weeks after nadroparine 2850 IE administration.
Background summary
Prophylatic low-molecular-weight heparin (LMWH) is effective in preventing
venous tromboembolism in patients with high risk, such as patients admitted to
a hospital. Furthermore, the effectivity of therapeutic LMWH is reduced in
overweight patients or patients with reduced kidney function. However, it is
not known whether this is also the case for the effectivity of prophylactic
LMWH.
Study objective
The objective of the study is to evaluate in a prospective setting the effect
of body weight on anti-Xa levels in the blood after administration of
prophylactic nadroparin 2850 IE to patients admitted to the hospital. Second,
we want to see what the effect is of kidney function on anti-Xa levels.
Study design
Prospective study, in which we will measure anti-Xa levels in 220 patienten
admitted to the hospital that have an indication for thrombosis prophylaxis
with nadroparine 2850 IE. Anti-Xa levels will be measured 4 hours after
administration of the nadroparin. Furthermore, in all patients body weight,
body-mass index, lean-body mass andkidney function will be measured. Finally we
will contact the patients by mail to ask whether a VTE or bleeding event has
occurred.
Study burden and risks
The treatment is standard procedure that will not contain any additional risk
for the study participants.
The burden concerns approximately 30 minutes of time, additional measurements
including and impedance measurement and an extra blood withdrawal of 3 mL. For
the second secondary study outcome, 4 subgroups of patients will be identified
in whom we will do a second anti-Xa level measurement 4 days after the first
(in case a patient is still admitted). This will require another blood
withdrawal of 3 mL.
Bosboomstraat 1
Utrecht 3582 KE
NL
Bosboomstraat 1
Utrecht 3582 KE
NL
Listed location countries
Age
Inclusion criteria
admission to the hospital for at least 1 night
indication for nadroparine 2850 IE prophylaxis
age > 18 years
signed informed consent
Exclusion criteria
presence of deep venous thrombosis or pulmonary embolism
use of Vitamin K antagonist or DOAC
trombocytes < 50 10*9/L
any other contra-indication for nadroparine 2850 IE
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65998.100.18 |
| OMON | NL-OMON29346 |