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Cerebral Bleeding in COVID-19 ARDS Patients on Veno-venous ECMO

Incidence of Bleeding Complications in Critically Ill COVID-19 Patients With Acute Respiratory Distress Syndrome on Veno-venous ECMO

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04853953
Enrollment
400
Registered
2021-04-22
Start date
2021-04-30
Completion date
2021-12-31
Last updated
2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Corona Virus Infection, Extracorporeal Membrane Oxygenation Complication

Brief summary

Critically ill patients with severe acute respiratory distress syndrome (ARDS) sometimes require treatment with veno-venous extracorporeal membrane oxygenation (ECMO) to support gas exchange. To prevent clotting of the ECMO circuit, these patients need to be anticoagulated. This protective anticoagulation also leeds to an increased bleeding risk. Most critically ill COVID-19 patients suffer from an ARDS and some require ECMO support. However, the optimal strategy and targets for the anticoagulation of these patients remain uncertain. Studies have shown that COVID-19 is associated with endotheliopathy probably leading to procoagulatory effects. On the other hand, the incidence of bleeding complications associated with this endotheliopathy is not clear and remains to be elucidated. Anticoagulation of COVID-19 patients on ECMO thus poses a challenge for clinicians. The hypothesis of the current project is that COVID-19 patients with ARDS on ECMO exhibit a higher number of bleeding complications compared to historical control patients with non-COVID-19 ARDS requiring ECMO support.

Detailed description

The primary aim of the project is to retrospectively analyze the incidence of bleeding complications (especially cerebral bleedings) in critically ill COVID-19 patients with ARDS requiring ECMO support. The incidences of bleeding will be compared with a historical control cohort of non-COVID-19 patients on ECMO support. The data analysis will be set up within a multicentric, retrospective study involving the University Hospital Zurich (Switzerland), the Medical School Hannover (Germany) and the University Hospital Bonn (Germany). The aim of the multicentric approach is to increase the case load and to improve the validity of the data, which could possibly have therapeutic implications in the future. Aside from demographic and baseline date, mortality and causes of death, comorbidities, the anticoagulation strategy (substance, targets of anticoagulation) and laboratory parameters of the anticoagulation during the bleeding events will be collected. Furthermore, the intensity of the ECMO treatment (blood flow, sweep gas flow, oxygen requirement) during the bleeding events and the catecholamine use during ECMO implantation will be analyzed. To enhance comparability, intensive care specific treatments (proning, sedation and analgesia, COVID-19 targeted therapy) will be collected and analyzed.

Interventions

OTHERIncidence of bleeding complications in ARDS patients on veno-venous ECMO

All bleeding complications (especially cerebral bleedings) will be analyzed in the study groups. At the bleeding event, laboratory parameters of coagulation will be collected and the intensity of the ECMO treatment

Sponsors

Hannover Medical School
CollaboratorOTHER
University Hospital, Bonn
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Critically ill patients with ARDS requiring ECMO support from all three study sites * age \> 18 years

Exclusion criteria

\- Presence of an objective, declared denial to participate

Design outcomes

Primary

MeasureTime frameDescription
Cerebral bleedings in critically ill ARDS patients requiring ECMO supportFrom date of inclusion of patients into the study, all outcome measures will be analyzed in a time-to-event analysis ranging from ICU admission up to the bleeding event, assessed up to six monthsCerebral bleedings will be analyzed and classified according to cerebral imaging (computed tomography, magnetic resonance tomography)

Secondary

MeasureTime frameDescription
Non-cerebral bleedings in critically ill ARDS patients requiring ECMO supportFrom date of inclusion of patients into the study, all outcome measures will be analyzed in a time-to-event analysis ranging from ICU admission up to the bleeding event, assessed up to six monthsBleedings will be classified according to the documentation in the electronic medical reports

Contacts

Primary ContactSascha David, Prof
Sascha.david@usz.ch0041442552204

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026