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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412304
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Christer Svensen, 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.

Condition or disease Intervention/treatment
Covid-19 Thromboembolic Events Bleeding Drug: Dose of Tinzaparin or Dalteparin

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Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : March 6, 2020
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : May 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412304


Locations
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Sweden
South General Hospital
Stockholm, Stockholms Län, Sweden, 11880
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Maria Cronhjort, PhD Karolinska Institutet, Department of Clinical Science and Education
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Responsible Party: Christer Svensen, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04412304    
Other Study ID Numbers: Anticoagulant therapy Covid-19
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dalteparin
Tinzaparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action