Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Evaluation of treatment with anti-seizure medication in comatose cardiac arrest patients with status epilepticus on continuous electroencephalographic (TELSTAR-2) |
| Participants (P) | Adult comatose patients after out of hospital cardiac arrest and successful cardiopulmonary resuscitation, admitted to the intensive care unit, with ESE on continuous EEG |
| Intervention (I) | Standard care completed with anti-seizure treatment according to protocols for clinically overt status epilepticus with the goal of definitive seizure suppression. |
| Control (C) | Standard of care |
| Outcome (O) | Functional recovery expressed as the score on the extended Glasgow Outcome Scale (eGOS) at six months after cardiac arrest |
| Trial Design | This will be a comparative effectiveness study, comparing two standard treatment regimens. We propose a prospective multicentre trial with randomised treatment allocation, open-label treatment, and blinded endpoint assessment in twenty-one intensive care units in the Netherlands and Belgium. |
| Sample Size | 150 (55 in Belgium) |
| Trial duration | 69 months |
| Budget | 480.000,00€ |
Trial team
| Sponsor | University of Twente |
| Chief Investigator | Prof. Dr. J. Hofmeijer |
| Belgian Coodinating Centre | Hopital Universitaire de Bruxelles (HUB) |
| Number of participating sites | 21 sites (8 in Belgium) |
