NCT04198792 Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
| NCT ID | NCT04198792 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2010-01-01 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2010-01-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. The selection process during CPR is challenging causing a general survival rate of just 2 out of 10, and the urgent need for better selection criteria has been emphasized. It it crucial to keep cardiac arrest times as short as possible, pre primed-ECMO can facilitate this. The ECMO treatment and the long CPR times of ECPR can also affect the measurements of the neurologic prognostication guidelines after cardiac arrest, making its validity uncertain in this specific cohort. Further, the long-term neuropsychological follow-up is limited to a few patients, making it uncertain if ECPR gives the survivors good long-term life satisfaction or just a prolonged life. Our overall aim is to optimize and improve the care pathway for ECPR patients by refining patient selection, assessing pre-primed ECMO, validating neurological prognostication guidelines, and understanding long-term outcomes and challenges faced by survivors. Specific Aim 1: Evaluating predictors for good neurological outcomes in ECPR and to develop and validate (internally and externally) an evidence-based selection tool for ECPR. Specific aim 2: To assess the sterility and function of pre-primed ECMO. Specific aim 3: To evaluate the applicability of current guidelines for neurological prognostication after cardiac arrest in ECPR patients, and to assess the predictive value of individual and combined neurological tests in this specific patient population. Specific aim 4: To determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction - by comprehensive follow-up visits with validated questionnaires and neuropsychology testing up to 12 years after the ECMO-treated cardiac arrest.
Eligibility Criteria
Inclusion Criteria: * ECMO-treated patients. Exclusion Criteria: * None
Contact & Investigator
Bengt Redfors, MD, PhD
PRINCIPAL INVESTIGATOR
The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden
Frequently Asked Questions
Who can join the NCT04198792 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04198792 currently recruiting?
Yes, NCT04198792 is actively recruiting participants. Contact the research team at bengt.redfors@vgregion.se for enrollment information.
Where is the NCT04198792 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT04198792 clinical trial?
NCT04198792 is sponsored by Sahlgrenska University Hospital. The principal investigator is Bengt Redfors, MD, PhD at The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden. The trial plans to enroll 700 participants.