Sterility and oxygenator function in pre-primed extracorporeal membrane oxygenation: A prospective clinical study.
Daniel Bengtsson, Bodil Jönsson, Bengt Redfors
https://pubmed.ncbi.nlm.nih.gov/38912528Actively Recruiting
Led by Sahlgrenska University Hospital · Updated on 2026-01-20
700
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying patients who receive extracorporeal cardiopulmonary resuscitation (ECPR) during cardiac arrest or extracorporeal membrane oxygenation (ECMO) treatment without cardiac arrest. The study aims to improve patient selection for ECPR by developing and validating a tool to predict good neurological outcomes. It also evaluates the sterility and function of pre-primed ECMO circuits, tests the accuracy of neurological prognostication guidelines for ECPR patients, and assesses survivors' long-term neuropsychological outcomes and life satisfaction up to 12 years after treatment. The study includes patients treated with ECMO during cardiac arrest and those treated with ECMO for circulatory failure without cardiac arrest as a comparison group. No interventions are performed as part of the study; instead, researchers observe and compare outcomes between these groups. The study monitors ECMO oxygenator function, cultures the pre-primed ECMO circuits to check for infection, and applies neurological tests to assess prognosis after cardiac arrest. Participants undergo long-term follow-up visits with validated questionnaires and neuropsychological testing for up to 12 years. These assessments evaluate life satisfaction, anxiety, depression, fatigue, cognitive function, and physical activity. Researchers also measure outcomes such as the Modified Rankin Scale after one year, performance of ECMO oxygenators, culture results from ECMO circuits, and the predictive value of neurological guidelines. The study collects detailed data to better understand the challenges faced by survivors and improve future care.
CONDITIONS
Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants who receive ECMO treatment are observed to assess ECMO oxygenator function and the incidence of positive cultures of pre-primed ECMO circuits and blood cultures.
Visits as needed during ECMO treatment for up to 90 days
Duration - 3 months to 12 years
Participants undergo long-term follow-up to assess survival, neurological outcomes, life satisfaction, cognitive function, anxiety, depression, mental fatigue, and physical activity.
Periodic visits for assessments over 3 months to 12 years
Total: 1 location
1
Sahlgrenska Academy at Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
B
Bengt Redfors, MD, PhD
A
Anna Henningsson, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Daniel Bengtsson, Bodil Jönsson, Bengt Redfors
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https://pubmed.ncbi.nlm.nih.gov/39395854