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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04412304
Enrollment
166
Registered
2020-06-02
Start date
2020-03-06
Completion date
2020-05-28
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Covid-19, Thromboembolic Events

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.

Interventions

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
28-days ICU mortality28 days from ICU-admission28-days ICU mortality from admission to the ICU. Discontinue of ICU-care to palliative care counts as death.

Secondary

MeasureTime frameDescription
Incidence of thromboembolic events28 days from ICU-admissionThromboembolic 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 events28 days from ICU-admissionThe 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-admissionICU-free days alive during 28 days from ICU-admission. Counts as 0 days if discharged to ward for palliative treatment.

Other

MeasureTime frameDescription
D-dimer levels in the three groups groups28 days from ICU-admissionD-dimer every day it is measured during first 28 days from ICU-admission.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026