drugset / Trial / NCT02056236
TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation
Completed
172 enrolled
University of Twente
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabCanisius-Wilhelmina Hospital · collabMaasstad Hospital · collabMaastricht University Medical Center · collabMedisch Spectrum Twente · collabRadboud University Medical Center · collabRijnstate Hospital · collabSt. Antonius Hospital · collabUniversity Medical Center Groningen · collabUniversité Libre de Bruxelles · collabVieCuri Medical Centre · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to estimate the effect of medical treatment of electro-encephalographic status epilepticus on neurological outcome of patients with postanoxic encephalopathy after cardiac arrest.
Timeline
- Start
- 2014-04
- Primary completion
- 2021-04-24
- Completion
- 2022-01-24
Outcome
Missed primary endpoint
paper At 3 months, 79 of 88 patients (90%) in the antiseizure-treatment group and 77 of 84 patients (92%) in the control group had a poor outcome (difference, 2 percentage points; 95% confidence interval, -7 to 11; P = 0.68). PMID 35196426 ↗
Publications
- Background Ruijter BJ, van Putten MJ, Horn J, Blans MJ, Beishuizen A, van Rootselaar AF, Hofmeijer J; TELSTAR study group. Treatment of electroencephalographic status epilepticus after cardiopulmonary resuscitation (TELSTAR): study protocol for a randomized controlled trial. Trials. 2014 Nov 6;15:433. doi: 10.1186/1745-6215-15-433.
- van Putten MJAM, Ruijter BJ, Horn J, van Rootselaar AF, Tromp SC, van Kranen-Mastenbroek V, Gaspard N, Hofmeijer J; TELSTAR Investigators. Quantitative Characterization of Rhythmic and Periodic EEG Patterns in Patients in a Coma After Cardiac Arrest and Association With Outcome. Neurology. 2024 Aug 13;103(3):e209608. doi: 10.1212/WNL.0000000000209608. Epub 2024 Jul 11.
- Ruijter BJ, Keijzer HM, Tjepkema-Cloostermans MC, Blans MJ, Beishuizen A, Tromp SC, Scholten E, Horn J, van Rootselaar AF, Admiraal MM, van den Bergh WM, Elting JJ, Foudraine NA, Kornips FHM, van Kranen-Mastenbroek VHJM, Rouhl RPW, Thomeer EC, Moudrous W, Nijhuis FAP, Booij SJ, Hoedemaekers CWE, Doorduin J, Taccone FS, van der Palen J, van Putten MJAM, Hofmeijer J; TELSTAR Investigators. Treating Rhythmic and Periodic EEG Patterns in Comatose Survivors of Cardiac Arrest. N Engl J Med. 2022 Feb 24;386(8):724-734. doi: 10.1056/NEJMoa2115998.
- Hofmeijer J, van Putten MJ. EEG in postanoxic coma: Prognostic and diagnostic value. Clin Neurophysiol. 2016 Apr;127(4):2047-55. doi: 10.1016/j.clinph.2016.02.002. Epub 2016 Feb 11.
- Ruijter BJ, van Putten MJ, Hofmeijer J. Generalized epileptiform discharges in postanoxic encephalopathy: Quantitative characterization in relation to outcome. Epilepsia. 2015 Nov;56(11):1845-54. doi: 10.1111/epi.13202. Epub 2015 Sep 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levetiracetam | Other / unclassified | 1000 mg | Intravenous |
| Subject | Lorazepam | Small molecule | — | — |
| Subject | Midazolam | Small molecule | — | — |
| Subject | Phenytoin | Unknown | 150 mg | Intravenous |
| Subject | Propofol | Small molecule | 8 mg/kg | — |
| Subject | Thiopental | Small molecule | 5 mg/kg | — |
| Subject | Valproic Acid | Small molecule | 15 mg/kg | Intravenous |