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

Completed

• Conditions: Covid19; Thromboembolism
• Interventions: Drug: Dose of tinzaparin or dalteparin

• Registration Number: NCT04593654
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-08-15
• Study Completion: 2020-10-15
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-18
• Study First Posted: 2020-10-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• laboratory confirmed positive test for SARS-CoV-2
• admitted to ICU because of respiratory failure caused by Covid-19

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high dose thromboprophylaxis	Dose of tinzaparin or dalteparin	Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin
low dose thromboprophylaxis	Dose of tinzaparin or dalteparin	Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin
medium dose thromboprophylaxis	Dose of tinzaparin or dalteparin	Daily dose of \>4500 IU but \<175 IU/kg of body weight tinzaparin or \>5000 IU but \<200 IU/kg of body weight dalteparin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Sweden