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

June 28, 2023 updated by: Rijnstate Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Monique de Maat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult ICU patients (COVID-19 and non-COVID-19 patients) using nadroparin with the intention of thrombosis prophylaxis are included. Anti Xa activity is determined once per patient at least 3 days (peak level after 4th administration) after admission at the ICU and on nadroparin treatment. No randomization.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Procedure: blood sampling
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.
Procedure: blood sampling
Blood sampling for the determination of anti-Xa peak levels 4 hours after administration of nadroparin sc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of anti-Xa peak level
Time Frame: 2 years
U/ml
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of anti-Xa levels within target range
Time Frame: 2 years
Amount of levels within target range (in %)
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

November 23, 2022

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/1725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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