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

Karolinska Institutet257 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

257

Conditions

Covid19 Thromboembolism

Interventions

Dose of tinzaparin or dalteparinDRUG

The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Södersjukhuset

Stockholm, Sweden

Outcomes

Primary Outcomes

28-day mortality

28-day mortality from admission to ICU. Discontinue of ICU-care to palliative care counts as death.

Time frame: 28 days from ICU-admission

Secondary Outcomes

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.

Time frame: 28 days from ICU-admission

Incidence of bleeding events

The event of bleeding will be defined by WHO modified bleeding scale as 1-4

Time frame: 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.

Time frame: 28 days from ICU-admission

90-day mortality

90-day mortality from admission to ICU.

Time frame: 90 days from ICU-admission

Data from ClinicalTrials.gov

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