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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose thromboprophylaxis | Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin |
| |
| medium dose thromboprophylaxis | Daily dose of >4500 IU but <175 IU/kg of body weight tinzaparin or >5000 IU but <200 IU/kg of body weight dalteparin |
| |
| high dose thromboprophylaxis | Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose of tinzaparin or dalteparin | Drug | The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fibrin-D-dimer levels | Median value of Fibrin-D-dimer | 28 days from ICU-admission |
Inclusion Criteria:
Exclusion Criteria:
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A cohort study of the critically ill Covid-19 patients admitted to ICU at Södersjukhuset, Stockholm from1st of March to 15 of July
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Jonmarker, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södersjukhuset | Stockholm | 11883 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34875111 | Derived | Jonmarker S, Litorell J, Dahlberg M, Stackelberg O, Everhov AH, Soderberg M, Rubenson-Wahlin R, Gunther M, Martensson J, Hollenberg J, Joelsson-Alm E, Cronhjort M. An observational study of intermediate- or high-dose thromboprophylaxis for critically ill COVID-19 patients. Acta Anaesthesiol Scand. 2022 Mar;66(3):365-374. doi: 10.1111/aas.14013. Epub 2021 Dec 16. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D013923 | Thromboembolism |
| D011655 | Pulmonary Embolism |
| D006470 | Hemorrhage |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017985 | Dalteparin |
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| 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 |
| 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 |
| D004617 | Embolism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002241 |
| Carbohydrates |