Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
NCT ID: NCT06464016
Last Updated: 2025-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
47 participants
OBSERVATIONAL
2023-07-04
2025-11-01
Brief Summary
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Long-term mechanical circulatory support is a major advance in the management of heart failure and can provide haemodynamic support while awaiting myocardial recovery or heart transplantation. The Berlin Heart (BH) EXCOR is the only long-term support system available for children.
Despite technical and medical advances in circulatory support, infection is a common complication and a major cause of morbidity and mortality in patients on BH.
There are few studies on the management of infection with mechanical support. Current ISHLT (International Society for Heart and Lung Transplantation) recommendations are based on expert opinion and observational studies. Some experts recommend anti-infective therapy until transplantation for specific support infections or for support-associated infections with persistent bacteraemia.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Pediatric patients with Berlin Heart EXCOR
Patient under 18 years old of age at the time of BH assistance in HCL Lyon France
Ventricular Assist Device with Berlin Heart EXCOR
The Berlin Heart® EXCOR is a type of "artificial heart" pump that pulls blood from the ventricle and then sends that blood to the aorta or pulmonary trunc, thereby taking away extra work from the native heart. The device, which comes in several sizes, is not totally implanted inside the body.
Interventions
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Ventricular Assist Device with Berlin Heart EXCOR
The Berlin Heart® EXCOR is a type of "artificial heart" pump that pulls blood from the ventricle and then sends that blood to the aorta or pulmonary trunc, thereby taking away extra work from the native heart. The device, which comes in several sizes, is not totally implanted inside the body.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* unavailable documentation
1 Day
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Claude Bernard University
OTHER
Responsible Party
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Lilot Marc
Official Director
Principal Investigators
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Luc Panetta, MD
Role: STUDY_DIRECTOR
Hospices Civils de Lyon
Locations
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Hospices Civils de Lyon
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AGORA n°23-5221
Identifier Type: -
Identifier Source: org_study_id
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