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| Name | Class |
|---|---|
| Lund University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with critical COVID-19 responding to LMWH treatment | Responders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH. |
| |
| Patients with critical COVID-19 not responding to LMWH treatment | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The effect of LMWH | Drug | Quantified by aFXa-levels |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 90-day mortality | 90 days from ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with critical COVID-19 and respiratory failure admitted to ICU at Södersjukhuset, Karolinska Sjukhuset and Skånes Universitetssjukhus, in Sweden, between March 1 2020 and May 31 2021 are eligible.
Patients will be included on their first admission to the ICU if admitted more than once. First admission can be replaced by the second one if the first one is considered very short/insignificant compared to the second one. If a patient is transferred from one ICU to another this will be considered the same admission but they will be grouped according to their initial ICU.
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Jonmarker, MD | Stockholm South General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 11883 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37784131 | Derived | Jonmarker S, Litorell J, Alarcon F, Al-Abani K, Bjorkman S, Farm M, Grip J, Soderberg M, Hollenberg J, Wahlin RR, Kander T, Rimling L, Martensson J, Joelsson-Alm E, Dahlberg M, Cronhjort M. A retrospective multicenter cohort study of the association between anti-Factor Xa values and death, thromboembolism, and bleeding in patients with critical COVID-19. Thromb J. 2023 Oct 2;21(1):101. doi: 10.1186/s12959-023-00541-z. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D013923 | Thromboembolism |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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anti-Factor Xa
| Monitoring frequency of aFXa-levels | Diagnostic Test | The frequency of aFXa-levels being sampled, analysed and integrated as a possible part of the basis for clinical decisionmaking |
|
| 28 days from ICU-admission |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |