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

NCT05926518 | Completed

• 1 other identifier: 2020/1725
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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. 1.To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups.
2. 2.To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.

Conditions

Critical Illness; Therapeutic Drug Monitoring; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Evaluation of anti-Xa peak level

  U/ml

  2 years

Secondary Outcomes (2)

• Percentage of anti-Xa levels within target range

  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

  2 years

Study Arms (2)

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

non-COVID-19 ICU patients

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

Procedure: blood sampling

Interventions

blood sampling PROCEDURE

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

COVID-19 ICU patients; non-COVID-19 ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• o (History of) Heparin Induced Thrombocytopenia and Thrombosis

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Monique de Maat

Arnhem, 6815 AD, Netherlands

Location

MeSH Terms

Conditions

Critical Illness; Venous Thromboembolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 3, 2023
• Study Start: November 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: November 23, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

NL (1)