Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Twente
About this trial
The goal of this comparative effectiveness trial is to study electrographic status epilepticus (ESE) treatment in comatose patients after cardiac arrest. The main questions the trial aims to answer are:
* Does ESE treatment improve outcome? * What is the impact of ESE treatment on healthcare costs?
Participants in the the intervention group will receive standard care completed with anti-seizure treatment. The control group will receive standard care without anti-seizure treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Coma (Glasgow Coma Scale score ≤ 8) after out of hospital cardiac arrest and resuscitation
Age ≥ 18 years
Continuous EEG with at least eight electrodes started < 24h after return of spontaneous circulation (ROSC)
ESE or possible ESE according to the Salzburg and ACNS criteria
Disqualifiers
Known history of another medical condition with limited life expectancy (< six months)
Any progressive brain illness, such as a brain tumor or neurodegenerative disease
Pre-admission Glasgow Outcome Scale score of 3 or lower
Reason other than the neurological condition to withdraw treatment
Trial design
Design model
Parallel
Treatments tested in this trial
anti-seizure medication + sedative agent(s)
DrugStepwise approach: 1. a single dose of a parenteral benzodiazepine (lorazepam, midazolam, or diazepam) and a first parenteral anti-seizure medication (levetiracetam, valproate, or lacosamide) 2. a second parenteral anti-seizure medication plus a first continuous parenteral sedative agent (midazolam or propofol) 3. a second continuous parenteral sedative agent (midazolam, propofol, or ketamine)
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Intervention groupOther 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
score on the extended Glasgow Outcome Scale (eGOS)
eGOS is an 8-points ordinal scale of functional recovery with possible scores ranging from 0 to 6. A higher score indicates better functional recovery
Time frame
6 months after cardiac arrestSecondary outcomes
1
quality adjusted life years (QALYs)
this is a measure of cost-effectiveness
Time frame
12 months after cardiac arrestOther outcomes
1
survival in months
this is a measure of survival
Time frame
12 months after cardiac arrest2
death (any cause), pneumonia, sepsis (according to sepsis 3 criteria), bleeding (any cause), cardiac arrhythmia (any associated with hemodynamic compromise), new cardiac arrest, or thrombopenia
these are safety outcomes
Time frame
12 months after cardiac arrest3
score on the Rankin Scale (mRS)
mRS is a 6-point ordinal functional recovery scale with possible scores ranging from 1 to 6. A lower score indicates better functional recovery.
Time frame
6 and 12 months after cardiac arrest4
score on the cerebral performance categories (CPC)
COC is a 5-point ordinal functional recovery scale with possible scores ranging from 1 to 5. A lower score indicates better functional recovery.
Time frame
6 and 12 months after cardiac arrestSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Twente
Lead sponsor
Erasme University Hospital
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Belgium Health Care Knowledge Centre
Collaborator
Source ClinicalTrials.gov