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

Incidence of Bleeding, Thrombosis and Transfusion Requirements in ICU Patients With COVID-19 Supported With Veno-venous Extracorporeal Membrane Oxygenation: a Single-center Retrospective Cohort Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Thrombosis; Bleeding; Transfusion Adverse Reaction; VV ECMO

Detailed Description

During the SARS-CoV-2 (COVID-19) pandemic millions of people were affected worldwide, some only experiencing minor symptoms whilst some developed acute respiratory distress syndrome (ARDS) requiring admission to the intensive care unit (ICU). ARDS is a life-threatening condition with mortality ranging from 35-48 %. Gas exchange can be severely impaired and, in some cases, conventional mechanical ventilation and adjunct therapies cannot accomplish adequate oxygenation. Veno-venous extracorporeal membrane oxygenation (V-V ECMO) is recommended as a rescue-support for refractory hypoxemia in ARDS also following COVID-19 infection and has been utilised widely. However, optimal management is difficult with prolonged ECMO duration in ARDS patients with COVID-19 and reported survival rates vary considerably 34-66

%. Complications include severe bleeding requiring more red cell transfusions and thrombotic complications, which are common despite increased risk of bleeding. Both bleeding and thrombosis are associated with increased mortality and balancing the opposing risks is challenging in daily management. On one hand, patients are routinely exposed to anticoagulant therapy (e.g. systemic heparin for the ECMO circuit operation), but on the other hand, patients are commonly exposed to blood product transfusions. The timing, monitoring, efficacy and safety of both blood product transfusion and anticoagulant therapy remains poorly understood. The investigators therefore 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.

Objectives

1. To assess the incidence, site and risks of bleeding and thrombo-embolic events in ICU patients with COVID-19 supported with V-V ECMO.
2. To assess the quantity of transfused blood products.
3. To assess the clinical practice of anticoagulant therapy in this cohort.
4. To assess the incidence of transfusions-related serious adverse events.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Andreas Bender Johsson, MD; Phone Number: 004535458947; Email: andreas.bender.jonsson@regionh.dk
• Study Contact Backup: Name: Vibeke Lind Joergensen, MD,PHD; Phone Number: 004560776283; Email: vibeke.lind.joergensen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of cardiothoracic anaesthsia and intensive care 4141
    • Contact: Vibeke Lind Jørgensen MD, pHD, consultant; Phone Number: 004535458947; Email: vibeke.lind.joergensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria:

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

Exclusion criteria:

- none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of blood products transfusion in the ICU	Number of units and estimated volume of red blood cells, platelets, fresh frozen plasma, fibrinogen concentrates, cryoprecipitate and anti-thrombin-III substitution	90 days
Use of anticoagulant therapy	Number of days on anticoagulant therapy and type of anticoagulant used in the ICU	90 days
Thrombo-embolic events	A thrombo-embolic event is defined as any radiologically proven event (i.e. ultrasound, CT- or MRI scan) or any event that led to a significant change in patient management (i.e. changes in anticoagulant therapy or requiring invasive interventions).	90 days
Transfusion-related serious adverse events	A serious adverse event defined as any event requiring immediate discontinuation of transfusion or deterioration of any organ system that has previously been unaffected by the underlying disease following transfusion (e.g. anaphylaxis, haemolytic reactions, TRALI, TACO).30	90 days

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 11, 2026
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Thrombosis; Hemorrhage
• Other Study ID Numbers: P-2025-19510; R-25054929 (Other Identifier: team for journaldata)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We dont know if other groups are interested in the data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No