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

NCT ID: NCT05926518

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-11-23

Brief Summary

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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

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Conditions

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Critical Illness Therapeutic Drug Monitoring Venous Thromboembolism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 ICU patients

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).

blood sampling

Intervention Type PROCEDURE

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

non-COVID-19 ICU patients

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

blood sampling

Intervention Type PROCEDURE

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

Interventions

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blood sampling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Monique de Maat

Arnhem, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2020/1725

Identifier Type: -

Identifier Source: org_study_id

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