Epilepsy Clinical Trial
— EPOCASOfficial title:
Incidence of Epileptic Potentials During Cardiac Surgery and Postoperative Neurological Outcome: A Prospective Observational Study
NCT number | NCT02976584 |
Other study ID # | KEK210/15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 11, 2016 |
Est. completion date | January 2018 |
Verified date | May 2018 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Primarily, the investigators want to test the hypothesis that it is possible to detect
epileptiform EEG during cardiac surgery under general anesthesia.
Furthermore, the investigators will examine if those epileptic potentials coincide, follow or
are unrelated to ischemic events detected by EEG or Near-infrared spectroscopy (NIRS).
Finally, the investigators will look for independent associations between intraoperative
seizures (with or without ischemic events) and postoperative neurological outcome, as well as
between intraoperative seizures (with or without ischemic events) and the total amount of TXA
given.
Status | Completed |
Enrollment | 1067 |
Est. completion date | January 2018 |
Est. primary completion date | November 24, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients that are undergoing elective or emergent cardiac or major aortic surgery with cardiopulmonary bypass. Exclusion Criteria: - Patients refusing to consent to our institutional protected health information policy on the consent document for anesthesia or the general consent of the INSELSPITAL. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Inselspital | Berne |
Lead Sponsor | Collaborator |
---|---|
Heiko Kaiser |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of intraoperative epileptic seizures | Up to 1 day | ||
Secondary | Neurologic injury (Stroke, PRIND, TIA) | up to 30 days | ||
Secondary | Delayed wakening from anesthesia | up to 30 days | ||
Secondary | Postoperative cardiac/pulmonary/renal complications | up to 30 days | ||
Secondary | Mortality | up to 30 days | ||
Secondary | Time on the ventilator | up to 30 days | ||
Secondary | ICU length of stay | up to 30 days | ||
Secondary | Hospital length of stay | up to 30 days |
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