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Completed

NCT Number: NCT04412304

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

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.

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Key information

Conditions

COVID-19 Bleeding Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Hemorrhage Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thromboembolic Events Thromboembolism Vascular Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

South General Hospital

Stockholm, Stockholm County, 11880, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dose of tinzaparin or dalteparin

Drug

The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.

Primary outcomes

  1. 28-days ICU mortality

    Time frame: 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 outcomes

  1. Incidence of thromboembolic events

    Time frame: 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.

  2. Incidence of bleeding events

    Time frame: 28 days from ICU-admission

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

  3. ICU-free days alive from ICU-admission.

    Time frame: 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.

Other outcomes

  1. D-dimer levels in the three groups groups

    Time frame: 28 days from ICU-admission

    D-dimer every day it is measured during first 28 days from ICU-admission.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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