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

Karolinska Institute

Status: Completed

Conditions: Thromboembolism; Covid19; Bleeding

Treatments: Diagnostic Test: Monitoring frequency of aFXa-levels; Drug: The effect of LMWH

Study type: Observational

Funder types: Other

Identifiers

NCT05256524

AntiFactorXa in Covid-19

Details and patient eligibility

About

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.

Enrollment: 1,520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with critical COVID-19 and respiratory failure
• Positive SARS-CoV-2 test
• LMWH-effect monitored by aFXa, as a trough or peak value, after at least four doses at a twice daily regime

Exclusion criteria

• Diagnosed thromboembolism or major bleeding during their COVID-illness prior to ICU-admission or as a reason or contributing factor for the ICU-admission.
• Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible

Trial design

1,520 participants in 2 patient groups

Patients with critical COVID-19 responding to LMWH treatment

Description:

Responders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

Treatment:

Drug: The effect of LMWH

Diagnostic Test: Monitoring frequency of aFXa-levels

Patients with critical COVID-19 not responding to LMWH treatment

Description:

Non-responders are defined as patients who do not achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.

Treatment:

Drug: The effect of LMWH

Diagnostic Test: Monitoring frequency of aFXa-levels