Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients (NADRO)

Rijnstate Hospital

Status: Completed

Conditions: Venous Thromboembolism; Therapeutic Drug Monitoring; Critical Illness

Treatments: Procedure: blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT05926518

2020/1725

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

62 participants in 2 patient groups

COVID-19 ICU patients

Description:

Patients were administered as standard care once daily nadroparin 5700 IU sc (below 100 kg) or twice daily nadroparin 5700 IU sc (above 100 kg).

Treatment:

Procedure: blood sampling

non-COVID-19 ICU patients

Description:

Patients were administered as standard care once daily nadroparin 2850 IU sc.

Treatment:

Procedure: blood sampling