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Is Anti-Factor Xa Associated With Outcome in Patients With Critical COVID-19 on Low-Molecular-Weight Heparin?

NCT05256524 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1520

Last updated 2022-02-25

No results posted yet for this study

Summary

Patients with critical COVID-19 are hyper-coagulable and optimal thromboprophylaxis treatment differs with stage and severity. The most commonly used drug for thromboprophylaxis in the intensive care unit (ICU) is low-molecular-weight heparin (LMWH). In contrast to unfractionated heparins, the effects of LMWH usually do not require monitoring. Exceptions from this are when elimination of LMWH is impaired, extremes in age and weight, to identify deviations from predicted pharmacokinetics, and if there is an unexpected clinical response. The unexpected high incidence of thromboembolic complications among patients with critical COVID-19 compared to critically ill non-COVID-19 patients could motivate monitoring. The activity of LMWH is monitored by quantifying the presence of anti-Factor Xa (aFXa). The aim of this study is to investigate if the level and the monitoring frequency of aFXa is associated to mortality, thrombosis and bleeding in patients with critical COVID-19 treated with LMWH and therefore could be used as a potential tool to guide LMWH-treatment.

Conditions

Interventions

DRUG

The effect of LMWH

Quantified by aFXa-levels

DIAGNOSTIC_TEST

Monitoring frequency of aFXa-levels

The frequency of aFXa-levels being sampled, analysed and integrated as a possible part of the basis for clinical decisionmaking

Sponsors & Collaborators

Principal Investigators

  • Sandra Jonmarker, MD · Stockholm South General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-05-31
Completion
2021-08-29

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256524 on ClinicalTrials.gov