Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up
Overview
- Phase
- Not Applicable
- Intervention
- Dose of tinzaparin or dalteparin
- Conditions
- Covid19
- Sponsor
- Karolinska Institutet
- Enrollment
- 257
- Locations
- 1
- Primary Endpoint
- 28-day mortality
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Sandra Jonmarker
Principal investigator, MD, PhD-student
Karolinska Institutet
Eligibility 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
Arms & Interventions
low dose thromboprophylaxis
Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin
Intervention: Dose of tinzaparin or 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
Intervention: Dose of tinzaparin or dalteparin
high dose thromboprophylaxis
Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin
Intervention: Dose of tinzaparin or dalteparin
Outcomes
Primary Outcomes
28-day mortality
Time Frame: 28 days from ICU-admission
28-day mortality from admission to ICU. Discontinue of ICU-care to palliative care counts as death.
Secondary Outcomes
- Incidence of thromboembolic events(28 days from ICU-admission)
- Incidence of bleeding events(28 days from ICU-admission)
- ICU-free days alive from ICU-admission(28 days from ICU-admission)
- 90-day mortality(90 days from ICU-admission)