Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| low dose thromboprophylaxis Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin |
Drug: Dose of tinzaparin or dalteparin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
Other Names:
|
| 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 |
Drug: Dose of tinzaparin or dalteparin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
Other Names:
|
| high dose thromboprophylaxis Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin |
Drug: Dose of tinzaparin or dalteparin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- Fibrin-D-dimer levels [28 days from ICU-admission]
Median value of Fibrin-D-dimer
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Södersjukhuset | Stockholm | Sweden | 11883 |
Sponsors and Collaborators
- Karolinska Institutet
Investigators
- Principal Investigator: Sandra Jonmarker, MD, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Thromboprophylaxis COVID-19