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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRigshospitalet, Denmark

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults

Polymerase chain reaction (PCR) verified COVID-19 infection

Supported with V-V ECMO in this center

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Patients with COVID-19 induced ARDS supported with VV ECMO in eastern Denmark

Trial outcomes

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

Time frame
90 days

Secondary outcomes

1

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).

Time frame
90 days
2

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

Time frame
90 days
3

Use of anticoagulant therapy

Number of days on anticoagulant therapy and type of anticoagulant used in the ICU

Time frame
90 days
4

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

Time frame
90 days

Other outcomes

Sponsors and contacts

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