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

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ClinicalTrials.gov Identifier: NCT04593654
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sandra Jonmarker, 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.

Condition or disease Intervention/treatment
Covid19 Thromboembolism Drug: Dose of tinzaparin or dalteparin

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Study Type : Observational
Actual Enrollment : 257 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : August 15, 2020
Actual Study Completion Date : October 15, 2020

Group/Cohort Intervention/treatment
low dose thromboprophylaxis
Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin
Drug: Dose of tinzaparin or dalteparin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
Other Name: Innohep/Fragmin

medium dose thromboprophylaxis
Daily dose of >4500 IU but <175 IU/kg of body weight tinzaparin or >5000 IU but <200 IU/kg of body weight dalteparin
Drug: Dose of tinzaparin or dalteparin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
Other Name: Innohep/Fragmin

high dose thromboprophylaxis
Daily dose of ≥ 175 IU/kg of body weight tinzaparin or ≥200 IU/kg of body weight dalteparin
Drug: Dose of tinzaparin or dalteparin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
Other Name: Innohep/Fragmin




Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: 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 :
  1. Incidence of thromboembolic events [ Time Frame: 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.

  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.

  4. 90-day mortality [ Time Frame: 90 days from ICU-admission ]
    90-day mortality from admission to ICU.


Other Outcome Measures:
  1. Fibrin-D-dimer levels [ Time Frame: 28 days from ICU-admission ]
    Median value of Fibrin-D-dimer



Information from the National Library of Medicine

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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 critically ill Covid-19 patients admitted to ICU at Södersjukhuset, Stockholm from1st of March to 15 of July
Criteria

Inclusion Criteria:

  • laboratory confirmed positive test for SARS-CoV-2
  • admitted to ICU because of respiratory failure caused by 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 date as ICU admission
  • patients without initial thromboprophylaxis

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): NCT04593654


Locations
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Sweden
Södersjukhuset
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Sandra Jonmarker, MD Karolinska Institutet
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Responsible Party: Sandra Jonmarker, Principal investigator, MD, PhD-student, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04593654    
Other Study ID Numbers: Thromboprophylaxis COVID-19
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandra Jonmarker, Karolinska Institutet:
Pulmonary embolism
Anticoagulation
Critical Care
Bleeding
Ischemic stroke
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