Skip to main content
OpenTrials
Completed

NCT Number: NCT04593654

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 Brain Diseases COVID-19 Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronaviridae Infections Coronavirus Infections Embolism Embolism and Thrombosis Hemorrhage Infections Ischemic Stroke Lung Diseases Nervous System Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pulmonary Embolism RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stroke Thromboembolism Vascular Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Södersjukhuset

Stockholm, 11883, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dose of tinzaparin or dalteparin

Drug

The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU

Other names: Innohep/Fragmin

Primary outcomes

  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 outcomes

  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 outcomes

  1. Fibrin-D-dimer levels

    Time frame: 28 days from ICU-admission

    Median value of Fibrin-D-dimer

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 20, 2020
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.