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

NCT04593654 | Completed

• 1 other identifier: Thromboprophylaxis COVID-19
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Thromboembolism

Keywords

Pulmonary embolism; Anticoagulation; Critical Care; Bleeding; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of thromboembolic events

  28 days from ICU-admission

• Incidence of bleeding events

  28 days from ICU-admission

• ICU-free days alive from ICU-admission

  28 days from ICU-admission

• 90-day mortality

  90 days from ICU-admission

Other Outcomes (1)

• Fibrin-D-dimer levels

  28 days from ICU-admission

Study Arms (3)

low dose thromboprophylaxis

Daily dose of 2500-4500 IU tinzaparin or 2500-5000 IU dalteparin

Drug: Dose of tinzaparin or dalteparin

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

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

Interventions

Dose of tinzaparin or dalteparin DRUG

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

Also known as: Innohep/Fragmin

high dose thromboprophylaxis; low dose thromboprophylaxis; medium dose thromboprophylaxis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• laboratory confirmed positive test for SARS-CoV-2
• admitted to ICU because of respiratory failure caused by Covid-19

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (1)

• Jonmarker S, Litorell J, Dahlberg M, Stackelberg O, Everhov AH, Soderberg M, Rubenson-Wahlin R, Gunther M, Martensson J, Hollenberg J, Joelsson-Alm E, Cronhjort M. An observational study of intermediate- or high-dose thromboprophylaxis for critically ill COVID-19 patients. Acta Anaesthesiol Scand. 2022 Mar;66(3):365-374. doi: 10.1111/aas.14013. Epub 2021 Dec 16.

  PMID: 34875111 DERIVED

MeSH Terms

Conditions

COVID-19; Thromboembolism; Pulmonary Embolism; Hemorrhage; Ischemic Stroke

Interventions

Dalteparin; Tinzaparin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Embolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sandra Jonmarker, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD-student

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 20, 2020
• Study Start: March 1, 2020
• Primary Completion: August 15, 2020
• Study Completion: October 15, 2020
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

SE (1)