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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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).
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
Use of anticoagulant therapy
Number of days on anticoagulant therapy and type of anticoagulant used in the ICU
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: