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

NCT04412304 | Completed

• 1 other identifier: Anticoagulant therapy Covid-19
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19; Thromboembolic Events; Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Other Outcomes (1)

• D-dimer levels in the three groups groups

  28 days from ICU-admission

Study Arms (3)

thrombose prophylaxis

The dose used to prevent thromboembolic complication in critically ill

Drug: Dose of Tinzaparin or Dalteparin

double thrombose prophylaxis

Double the dose used to prevent thromboembolic complication in critically ill

Drug: Dose of Tinzaparin or Dalteparin

full dose anticoagulant

Dose used to treat thromboembolic event

Drug: Dose of Tinzaparin or Dalteparin

Interventions

Dose of Tinzaparin or Dalteparin DRUG

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

double thrombose prophylaxis; full dose anticoagulant; thrombose prophylaxis

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 Covid-19 patients admitted to an ICU at Stockholm South General Hospital from March 6th 2020 to April 30 2020

You may qualify if:

• laboratory confirmed positive test for SARS-CoV-2
• admitted to ICU because of critical illness due to 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 or the following day as ICU admission

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

South General Hospital

Stockholm, Stockholm County, 11880, Sweden

Location

Related Publications (1)

• Jonmarker S, Hollenberg J, Dahlberg M, Stackelberg O, Litorell J, Everhov AH, Jarnbert-Pettersson H, Soderberg M, Grip J, Schandl A, Gunther M, Cronhjort M. Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients. Crit Care. 2020 Nov 23;24(1):653. doi: 10.1186/s13054-020-03375-7.

  PMID: 33225952 DERIVED

MeSH Terms

Conditions

COVID-19; Thromboembolism; Hemorrhage

Interventions

Dalteparin

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Maria Cronhjort, PhD

  Karolinska Institutet, Department of Clinical Science and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 2, 2020
• Study Start: March 6, 2020
• Primary Completion: April 30, 2020
• Study Completion: May 28, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

SE (1)