Treatment of ELectroencephalographic STatus epilepticus After cardiopulmonary Resuscitation-2 (TELSTAR-2): a multicenter randomised clinical trial and health economic evaluation of anti-seizure treatment in comatose cardiac arrest patients with status epilepticus on continuous EEG.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 19
- 主要终点
- 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. eGOS scores at six months are obtained by a standardized telephone interview conducted by an independent investigator, who is masked to treatment allocation and EEG pattern.
研究概览
简要总结
To determine if seizure suppression by stepwise anti-seizure treatment improves outcome of comatose patients after cardiac arrest with ESE, as compared with no anti-seizure treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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 cir-culation (ROSC)
- •ESE or possible ESE according to the Salzburg and ACNS criteria
- •Possibility to start treatment within three hours after detection of ESE
排除标准
- •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
- •EEG background activity prior to the emergence of ESE indicative of extensive irreversible anoxic brain injury
- •Follow-up impossible due to logistic reasons, for example not living in the Netherlands or Belgium
- •Insufficient understanding of the Dutch or French language.
- •Known hypersensitivity to the anti-seizure medication recommended for the intervention group (of note, in case of hypersensitivity to one or two of the recommended medications, the patient can be included, provided that medications at stake will not be used)
结局指标
主要结局
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. eGOS scores at six months are obtained by a standardized telephone interview conducted by an independent investigator, who is masked to treatment allocation and EEG pattern.
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. eGOS scores at six months are obtained by a standardized telephone interview conducted by an independent investigator, who is masked to treatment allocation and EEG pattern.
次要结局
- Cost-effectiveness analysis outcomes are Quality Adjusted Life Years (QALYs), costs, Incremental Cost Effectiveness Ratio (ICER), incremental cost-effectiveness plane, and incremental cost-effectiveness acceptability curve.
研究者
prof.dr. J. Hofmeijer
Scientific
Universiteit Twente