Bleeding, Covid19, Thromboembolism
Conditions
Keywords
Low-molecular-weight Heparin, Anti-Factor Xa, Critical Care
Brief 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.
Interventions
DRUGThe effect of LMWH
Quantified by aFXa-levels
DIAGNOSTIC_TESTMonitoring 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
Lund University
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 90 days from ICU admission | 90-day mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thromboembolic events | 28 days from ICU-admission | 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. |
| Bleeding events | 28 days from ICU-admission | 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. |
Countries
Sweden
Outcome results
None listed