Covid19, Thromboembolism
Conditions
Keywords
Pulmonary embolism, Anticoagulation, Critical Care, Bleeding, Ischemic stroke
Brief summary
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.
Interventions
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
Sponsors
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | 28 days from ICU-admission | 28-day mortality from admission to ICU. Discontinue of ICU-care to palliative care counts as death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of thromboembolic events | 28 days from ICU-admission | 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. |
| Incidence of bleeding events | 28 days from ICU-admission | The event of bleeding will be defined by WHO modified bleeding scale as 1-4 |
| ICU-free days alive from ICU-admission | 28 days from ICU-admission | ICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment. |
| 90-day mortality | 90 days from ICU-admission | 90-day mortality from admission to ICU. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fibrin-D-dimer levels | 28 days from ICU-admission | Median value of Fibrin-D-dimer |
Countries
Sweden
Outcome results
None listed