Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients

Study Overview
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Brief Summary
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The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.

Official Title
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Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up

Conditions
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Covid19, Thromboembolism

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 respiratory failure caused by 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 date as ICU admission patients without initial thromboprophylaxis
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 |
| --- | --- |
| low dose thromboprophylaxis<br>Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin | Drug: Dose of tinzaparin or dalteparin<br>* The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU<br>* Other names: Innohep/Fragmin;|
| medium dose thromboprophylaxis<br>Daily dose of >4500 IU but <175 IU/kg of body weight tinzaparin or >5000 IU but <200 IU/kg of body weight dalteparin | Drug: Dose of tinzaparin or dalteparin<br>* The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU<br>* Other names: Innohep/Fragmin;|
| high dose thromboprophylaxis<br>Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin | Drug: Dose of tinzaparin or dalteparin<br>* The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU<br>* Other names: Innohep/Fragmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | 28-day mortality from admission to 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) and ischemic stroke. 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. | 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 | 
| 90-day mortality | 90-day mortality from admission to ICU. | 90 days from ICU-admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary embolism, Anticoagulation, Critical Care, Bleeding, Ischemic stroke