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

Covid19 Clinical Trial

Official title:

Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients - More Patients Included and 90-day Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593654
• Other study ID #: Thromboprophylaxis COVID-19
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: May 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: October 15, 2020
• Est. primary completion date: August 15, 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 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Thromboembolism

Intervention

Drug:
• Dose of tinzaparin or dalteparin
The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fibrin-D-dimer levels	Median value of Fibrin-D-dimer	28 days from ICU-admission
Primary	28-day mortality	28-day mortality from admission to 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) 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.	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
Secondary	90-day mortality	90-day mortality from admission to ICU.	90 days from ICU-admission