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

Covid-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412304
• Other study ID #: Anticoagulant therapy Covid-19
• Status: Completed
• Start date: March 6, 2020
• Est. completion date: May 28, 2020

Study information

• Verified date: June 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: May 28, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Covid-19
• Thromboembolic Events
• Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
Sweden	South General Hospital	Stockholm	Stockholms Län

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	Incidence of bleeding events	The event of bleeding will be defined by WHO modified bleeding scale as 1-4.	28 days from ICU-admission
Secondary	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