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Completed

NCT Number: NCT05926518

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

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.

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Key information

Conditions

Critical Illness Cardiovascular Diseases Disease Attributes Embolism and Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Therapeutic Drug Monitoring Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monique de Maat

Arnhem, 6815 AD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

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

Primary outcomes

  1. Evaluation of anti-Xa peak level

    Time frame: 2 years

    U/ml

Secondary outcomes

  1. Percentage of anti-Xa levels within target range

    Time frame: 2 years

    Amount of levels within target range (in %)

  2. Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level

    Time frame: 2 years

    relevant correlation

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Acronym: NADRO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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