Critical Illness, Therapeutic Drug Monitoring, Venous Thromboembolism
Conditions
Brief summary
Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients. Secondary objectives 1. To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups. 2. To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.
Interventions
PROCEDUREblood sampling
Blood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc.
Sponsors
Rijnstate Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All COVID-19 patients \> 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc * All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc. * Minimum estimated length of stay on the ICU of 4 days
Exclusion criteria
o (History of) Heparin Induced Thrombocytopenia and Thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of anti-Xa peak level | 2 years | U/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of anti-Xa levels within target range | 2 years | Amount of levels within target range (in %) |
| Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level | 2 years | relevant correlation |
Countries
Netherlands
Outcome results
None listed