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

Rigshospitalet

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07352072

P-2025-19510

R-25054929 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

- none

Trial design

50 participants in 1 patient group

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

Description:

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.