Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients

Completed

• Conditions: Thromboembolic Events; Bleeding; Covid-19
• Interventions: Drug: Dose of Tinzaparin or Dalteparin

• Registration Number: NCT04412304
• Lead Sponsor: Karolinska Institutet

Brief Summary

The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.

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: 2020-03-06
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-28
• Study First Submitted: 2020-05-30
• Study First Submitted QC: 2020-05-30
• Status Verified: 2020-06
• Study First Posted: 2020-06-02
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• laboratory confirmed positive test for SARS-CoV-2
• admitted to ICU because of critical illness due to 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 or the following day as ICU admission

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
thrombose prophylaxis	Dose of Tinzaparin or Dalteparin	The dose used to prevent thromboembolic complication in critically ill
double thrombose prophylaxis	Dose of Tinzaparin or Dalteparin	Double the dose used to prevent thromboembolic complication in critically ill
full dose anticoagulant	Dose of Tinzaparin or Dalteparin	Dose used to treat thromboembolic event

Primary Outcome Measures

Name	Time	Method
28-days ICU mortality	28 days from ICU-admission	28-days ICU mortality from admission to the 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), ischemic stroke and other peripheral arterial emboli. 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. Peripheral arterial emboli are defined as peripheral arterial emboli 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.

Trial Locations

Locations (1)

South General Hospital; 🇸🇪 Stockholm, Stockholms Län, Sweden