Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients

Study Overview
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Brief Summary
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The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.

Official Title
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Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden

Conditions
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Covid-19, Thromboembolic Events, Bleeding

Intervention / Treatment
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* Drug: Dose of Tinzaparin or Dalteparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: laboratory confirmed positive test for SARS-CoV-2 admitted to ICU because of critical illness due to covid-19 Exclusion Criteria: patients with treatment for thromboembolic complications at arrival to the ICU short ICU length of stay defined as discharged the same or the following day as ICU admission
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| thrombose prophylaxis<br>The dose used to prevent thromboembolic complication in critically ill | Drug: Dose of Tinzaparin or Dalteparin<br>* The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.<br>|
| double thrombose prophylaxis<br>Double the dose used to prevent thromboembolic complication in critically ill | Drug: Dose of Tinzaparin or Dalteparin<br>* The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.<br>|
| full dose anticoagulant<br>Dose used to treat thromboembolic event | Drug: Dose of Tinzaparin or Dalteparin<br>* The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-days ICU mortality | 28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death. | 28 days from ICU-admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thromboembolic events | Thromboembolic events are defined as pulmonary emboli (PE), deep venous thrombus (DVT), ischemic stroke and other peripheral arterial emboli. PE is defined as PE verified by computer tomography or by findings of acute strain of the right heart on echocardiography combined with a clinical interpretation of the patients deteriorating as a probable PE stated in the medical records. DVT is defined as DVT verified with ultrasound. Ischemic stroke is defined as ischemic stroke verified by computer tomography. Peripheral arterial emboli are defined as peripheral arterial emboli verified by computer tomography. | 28 days from ICU-admission | 
| Incidence of bleeding events | The event of bleeding will be defined by WHO modified bleeding scale as 1-4. | 28 days from ICU-admission | 
| ICU-free days alive from ICU-admission. | ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment. | 28 days from ICU-admission |