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

Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden

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.

Study Overview

• Status: Completed
• Conditions: Covid-19; Bleeding; Thromboembolic Events
• Intervention / Treatment: Drug: Dose of Tinzaparin or Dalteparin

• Study Type: Observational
• Enrollment (Actual): 166

Contacts and Locations

Study Locations

• Sweden
  • Stockholms Län
    • Stockholm, Stockholms Län, Sweden, 11880
      • South General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A cohort study of the Covid-19 patients admitted to an ICU at Stockholm South General Hospital from March 6th 2020 to April 30 2020

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
thrombose prophylaxis; The dose used to prevent thromboembolic complication in critically ill	Drug: Dose of Tinzaparin or Dalteparin; The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.
double thrombose prophylaxis; Double the dose used to prevent thromboembolic complication in critically ill	Drug: Dose of Tinzaparin or Dalteparin; The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.
full dose anticoagulant; Dose used to treat thromboembolic event	Drug: Dose of Tinzaparin or Dalteparin; The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-days ICU mortality	28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.	28 days from ICU-admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of thromboembolic events	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.	28 days from ICU-admission
Incidence of bleeding events	The event of bleeding will be defined by WHO modified bleeding scale as 1-4.	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.	28 days from ICU-admission

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
D-dimer levels in the three groups groups	D-dimer every day it is measured during first 28 days from ICU-admission.	28 days from ICU-admission

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Maria Cronhjort, PhD, Karolinska Institutet, Department of Clinical Science and Education

Publications and helpful links

General Publications

• Jonmarker S, Hollenberg J, Dahlberg M, Stackelberg O, Litorell J, Everhov ÅH, Järnbert-Pettersson H, Söderberg M, Grip J, Schandl A, Günther M, Cronhjort M. Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients. Crit Care. 2020 Nov 23;24(1):653. doi: 10.1186/s13054-020-03375-7.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: May 30, 2020
• First Submitted That Met QC Criteria: May 30, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Embolism and Thrombosis; COVID-19; Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: Anticoagulant therapy Covid-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No