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

Covid19 Clinical Trial

— AntiXCOVID  

Official title:

Is Anti-Factor Xa Associated With Mortality, Thromboembolism and Bleeding in Patients With Critical COVID-19 Patients on Low-Molecular-Weight Heparin?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256524
• Other study ID #: AntiFactorXa in Covid-19
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: August 29, 2021

Study information

• Verified date: February 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1520
• Est. completion date: August 29, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• COVID-19
• Covid19
• Hemorrhage
• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	90-day mortality	90 days from ICU admission
Secondary	Thromboembolic events	Thromboembolic events are defined as the cumulative proportion of pulmonary embolism (PE), ischemic stroke and deep venous thrombosis (DVT).; PE must be verified by computed tomography or by clinical suspicion as cause of deterioration combined with findings of acute strain of the right heart on echocardiography. Ischemic stroke must be verified by computed tomography. DVT must by verified by ultrasound or by computed tomography.	28 days from ICU-admission
Secondary	Bleeding events	Bleeding events are categorized according to the World health organization (WHO) bleeding scale: 1) Petechiae, tissue hematoma, oropharyngeal bleeding, 2) Mild blood loss, hematemesis, macroscopic hematuria, hemoptysis, joint bleeding, 3) Gross blood loss requiring red blood cell transfusion and/or hemodynamic instability, 4) Debilitating blood loss, severe hemodynamic instability, fatal bleeding, or central nervous system bleeding.	28 days from ICU-admission