Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549426
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 TELSTAR-2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment of ELectrographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 Multicenter Randomised Clinical Trial and Health Economic Evaluation of Anti-seizure Treatment in Comatose Cardiac Arrest Patients With SE on Continuous EEG
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELSTAR-2
Brief Summary:
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
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
Detailed Description:
Rationale Around 7500 comatose patients after cardiac arrest and resuscitation are admitted to intensive care units ICUs in the Netherlands and Belgium yearly Approximately half eventually dies from severe brain injury EEG is used as a predictor of outcome helping decide whether life sustaining therapies should be pursued or withdrawn EEG shows epileptiform patterns meeting criteria for electrographic status epilepticus ESE in up to 10 of patients with 80-100 case fatality With the TELSTAR-1 trial we showed that anti-seizure treatment of unselected patients with epileptiform patterns is not associated with a better outcome However it remains unclear whether treatment of possible ESE will improve outcome or if ESE simply represents irreversible severe brain damage in which case such treatment will be futile This translates into ongoing practice variation To provide comatose cardiac arrest survivors with the best medical treatment options while at the same time preventing unnecessary costly ICU treatment unequivocal evidence of efficacy or futility of ESE treatment is needed
Objectives It is the primary objective to study whether ESE treatment improves outcome of comatose patients after cardiac arrest It is the secondary objective to study the impact on healthcare costs of ESE treatment
Main trial endpoints The primary outcome measure will be functional recovery expressed as the score on the extended Glasgow Outcome Scale eGOS at six months after cardiac arrest The primary effect parameter will be the common odds ratio for any shift towards a better outcome in the intervention group analyzed by multivariable ordinal logistic regression
Secondary trial endpoints Secondary outcome measures include data on quality of life cognitive functioning and the use of resources Cost-effectiveness will be assessed separately for Belgium and for the Netherlands adhering to KCE and Zorginstituut guidelines for pharmaco-economic evaluations respectively
Trial design This will be a comparative effectiveness study comparing two standard treatment regimens We will conduct a prospective multicentre trial with randomized treatment allocation open label treatment and blinded endpoint assessment on twenty intensive care units in the Netherlands and Belgium
Trial population The study population consists of adult comatose patients after out of hospital cardiac arrest and successful cardiopulmonary resuscitation admitted on the intensive care unit of any of the participating centres with ESE on continuous EEG Continuous EEG is part of standard care in all participating hospitals For the definition of ESE we adhere to international consensus criteria
Interventions Treatment in the intervention group will consist of standard care completed with anti-seizure treatment according to protocols for clinically overt status epilepticus with the goal of definitive seizure suppression This consists of a stepwise approach step 1 being a single dose of a parenteral benzodiazepine lorazepam midazolam or diazepam and a first parenteral anti-seizure medication levetiracetam valproate or lacosamide step 2 a second parenteral anti-seizure medication plus a first continuous parenteral sedative agent midazolam or propofol and step 3 a second continuous parenteral sedative agent midazolam propofol or ketamine Each next step will be taken as soon as possible within 30 minutes if the previous step was insufficiently effective to suppress ESE The control group will receive standard care without anti-seizure treatment
Objectives It is the primary objective to study whether ESE treatment improves outcome of comatose patients after cardiac arrest It is the secondary objective to study the impact on healthcare costs of ESE treatment
Main trial endpoints The primary outcome measure will be functional recovery expressed as the score on the extended Glasgow Outcome Scale eGOS at six months after cardiac arrest The primary effect parameter will be the common odds ratio for any shift towards a better outcome in the intervention group analyzed by multivariable ordinal logistic regression
Secondary trial endpoints Secondary outcome measures include data on quality of life cognitive functioning and the use of resources Cost-effectiveness will be assessed separately for Belgium and for the Netherlands adhering to KCE and Zorginstituut guidelines for pharmaco-economic evaluations respectively
Trial design This will be a comparative effectiveness study comparing two standard treatment regimens We will conduct a prospective multicentre trial with randomized treatment allocation open label treatment and blinded endpoint assessment on twenty intensive care units in the Netherlands and Belgium
Trial population The study population consists of adult comatose patients after out of hospital cardiac arrest and successful cardiopulmonary resuscitation admitted on the intensive care unit of any of the participating centres with ESE on continuous EEG Continuous EEG is part of standard care in all participating hospitals For the definition of ESE we adhere to international consensus criteria
Interventions Treatment in the intervention group will consist of standard care completed with anti-seizure treatment according to protocols for clinically overt status epilepticus with the goal of definitive seizure suppression This consists of a stepwise approach step 1 being a single dose of a parenteral benzodiazepine lorazepam midazolam or diazepam and a first parenteral anti-seizure medication levetiracetam valproate or lacosamide step 2 a second parenteral anti-seizure medication plus a first continuous parenteral sedative agent midazolam or propofol and step 3 a second continuous parenteral sedative agent midazolam propofol or ketamine Each next step will be taken as soon as possible within 30 minutes if the previous step was insufficiently effective to suppress ESE The control group will receive standard care without anti-seizure treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None