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NCT05926518 Clinical Trial

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

Critical Illness Clinical Trial

— NADRO  

Official title:
Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05926518
Other study ID # 2020/1725
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date November 23, 2022

Study information
Verified date June 2023
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date November 23, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• blood sampling
Blood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc.

Locations
Country Name City State
Netherlands Monique de Maat Arnhem

Sponsors (1)
Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of anti-Xa peak level U/ml 2 years
Secondary Percentage of anti-Xa levels within target range Amount of levels within target range (in %) 2 years
Secondary Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level relevant correlation 2 years
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