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

Completed

• Conditions: Therapeutic Drug Monitoring; Venous Thromboembolism; Critical Illness

• Registration Number: NCT05926518
• Lead Sponsor: Rijnstate Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2022-04-01
• Study Completion: 2022-11-23
• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of anti-Xa peak level	2 years	U/ml

Secondary Outcome Measures

Name	Time	Method
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
Percentage of anti-Xa levels within target range	2 years	Amount of levels within target range (in %)

Trial Locations

Locations (1)

Monique de Maat; 🇳🇱 Arnhem, Netherlands