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

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05926518
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Actual Duration (Months): 24.7
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness; Therapeutic Drug Monitoring; Venous Thromboembolism	Procedure: blood sampling

Study Design

• Study Type: Observational
• Actual Enrollment: 62 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU
• Actual Study Start Date: Nov 1, 2020
• Actual Primary Completion Date: Apr 1, 2022
• Actual Study Completion Date: Nov 23, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Evaluation of anti-Xa peak level [2 years]

   U/ml

Secondary Outcome Measures

1. Percentage of anti-Xa levels within target range [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 [2 years]

   relevant correlation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Monique de Maat	Arnhem		Netherlands	6815 AD

Sponsors and Collaborators

• Rijnstate Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rijnstate Hospital
• ClinicalTrials.gov Identifier: NCT05926518
• Other Study ID Numbers: 2020/1725
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thromboembolism; Venous Thromboembolism; Critical Illness

Study Results

No Results Posted as of Jul 3, 2023