Incidence of Bleeding, Thrombosis and Transfusion Requirements in ICU Patients With COVID-19 Supported With Veno-venous Extracorporeal Membrane Oxygenation

NCT07352072 | Not Yet Recruiting

• 2 other identifiers: P-2025-19510R-25054929
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to assess the risk of bleeding and thrombo-embolic complications as well as benefit and harm of blood product transfusion and anticoagulation therapy in adult ICU patients with COVID-19 supported with V-V ECMO

Conditions

VV ECMO; Bleeding; Thrombosis; Transfusion Adverse Reaction; COVID-19

Outcome Measures

Primary Outcomes (1)

• Bleeding events

  A bleeding event is defined as any event requiring at least 3 units of red blood cells within 24 hours or transfusion with 3 or more units of either fresh frozen plasma, platelet concentrates or red blood cells within 24 hours, any intracranial bleeding or bleeding requiring invasive/surgical interventions

  90 days

Secondary Outcomes (4)

• Thrombo-embolic events

  90 days

• Use of blood products transfusion in the ICU

  90 days

• Use of anticoagulant therapy

  90 days

• Transfusion-related serious adverse events

  90 days

Study Arms (1)

Patients with COVID-19 induced ARDS supported with VV ECMO in eastern Denmark

a single-center retrospective cohort study of all adult ICU patients with COVID-19 infection supported with veno-venous extracorporeal membrane oxygenation admitted to the cardio-thoracic intensive care unit at Copenhagen University Hospital, Rigshospitalet.

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

The investigators will conduct a single-center retrospective cohort study of all adult ICU patients with COVID-19 infection supported with veno-venous extracorporeal membrane oxygenation admitted to the cardio-thoracic intensive care unit at Copenhagen University Hospital, Rigshospitalet. The department represents one of two ECMO sites in Denmark and has a referral area inhabiting approximately 2.75 million people. Study period: February 26th 2020 (date of the first officially verified Danish patient infected with COVID-19) until December 31st 2021 (date of the last verified COVID-19 patient supported with V-V ECMO in this center). Patients will be followed from time of specialised ICU admission to death or a maximum of 90 days.

You may qualify if:

• Adults
• Polymerase chain reaction (PCR) verified COVID-19 infection
• Supported with V-V ECMO in this center

You may not qualify if:

• \- none

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of cardiothoracic anaesthsia and intensive care 4141

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hemorrhage; Thrombosis; COVID-19

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Andreas Bender Johsson, MD

CONTACT

004535458947; andreas.bender.jonsson@regionh.dk

Vibeke Lind Joergensen, MD,PHD

CONTACT

004560776283; vibeke.lind.joergensen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, pHD, consultant

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DK (1)