TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation
TELSTAR
TELSTAR
Sponsor study identifier
Secondary identifiers
OTHER · VCMO the Netherlands
interventional
172
2 countries
11
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 24, 2021
Actual (reported)Study Completion
January 24, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 24, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 4, 2014
Actual (reported)February 5, 2014
Actual (reported)April 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2021
Actual (reported)January 24, 2022
Actual (reported)Neurological outcome
The primary outcome measure will be neurological outcome defined as the score on the Cerebral Performance Category (CPC) at 3 months dichotomized as good (CPC 1-2 = no or moderate neurological disability) and poor (CPC 3-5 = severe disability, coma, or death).
three months
Long term outcome
12 months
Step 1: Phenytoin (loading dose 15-20 mg/kg iv, maintenance doses 150 mg iv twice per day) PLUS one of the following benzodiazepines (bolus + continuous infusion): lorazepam or midazolam. Benzodiazepine dosing regimes should be based on national and local protocols for status epilepticus treatment Step 2: Propofol infusion (with a maximum rate of 8 mg/kg/hour) PLUS a second anti-epileptic drug in addition to fenytoin: Option 1: levetiracetam bolus 1500 mg, followed by 1000 mg 2 dd 1 intravenously or Option 2: valproic acid bolus 10-20 mg/kg in 30 min, followed by15 mg/kg/day in 2 dosages intravenously. Step 3: Thiopental, initial dosage 12,5 mg/kg/hr for the first 6 hours followed by 5 mg/kg/hr for 6 hours. After these loading dosages, treatment should be guided by the EEG pattern.
The non-intervention group will be treated conform standard guidelines of treatment of comatose patients after cardiac arrest, but without anti-epileptic drugs or EEG based deep sedation. Treatment to suppress clinical myoclonia or seizures with low dose propofol is left to the discretion of the treating physician. Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline "postanoxic coma" in both treatment arms. Reasons for withdrawal of treatment will be documented.
Recommendations for the treatment of status epilepticus are based on recent international guidelines for treatment of overt status epilepticus. The objective of treatment with AED is to suppress all epileptiform activity. There is no clear proof that induction of a burst-suppression pattern is of additional value and induction of burst suppression is therefore not obligate. If the electroencephalographic status epilepticus returns after tapering sedative treatment at 24 hours, the procedure will be repeated. If the status returns after 2 x 24 hours, it will be considered refractory. Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline "postanoxic coma". Reasons for withdrawal of treatment will be documented.
Hôpital Erasme - Université libre de Bruxelles
Brussels, Lenniksebaan 808, 1070, Belgium
Radboud University Medical Center
Nijmegen, Geert Grooteplein-Zuid 10, 6525 GA, Netherlands
Medisch Spectrum Twente
Enschede, Haaksbergerstraat 55, 7513 ER, Netherlands
University Medical Center Groningen
Groningen, Hanzeplein 1, 9700 RB, Netherlands
St. Antonius Hospital
Nieuwegein, Koekoekslaan 1, 3430 EM, Netherlands
Academic Medical Center
Amsterdam, Meibergdreef 9, 1105 AZ, Netherlands
Maasstad Hospital
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.
Jeannette Hofmeijer, MD PhD
Rijnstate Hospital and University of Twente
Michel van Putten, MD PhD
Medisch Spectrum Twente and University of Twente
Janneke Horn, MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Barry Ruijter, MD
University of Twente
172 participants (actual enrollment reported by the registry).
First Submitted
February 4, 2014
First Posted
February 5, 2014
Study Start
April 2014
Date type not reportedThis date has not been verified as actual or estimated.
Use of a Metronome in Cardiopulmonary Resuscitation: A Simulation Study
The non-intervention group will be treated conform standard guidelines of treatment of comatose patients after cardiac arrest, but without anti-epileptic drugs or EEG based deep sedation. Treatment to suppress clinical myoclonia or seizures with low dose propofol is left to the discretion of the treating physician. Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline "postanoxic coma". Reasons for withdrawal of treatment will be documented.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Rotterdam, South Holland, 3079 DZ, Netherlands
VieCuri Medical Centre
Venlo, Tegelseweg 210, 5912 BL, Netherlands
Rijnstate Hospital
Arnhem, Wagnerlaan 55, 6815 AD, Netherlands
Maastricht UMC+
Maastricht, Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands
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.
Primary Completion
April 24, 2021
Actual (reported)Study Completion
January 24, 2022
Actual (reported)Last Updated
February 21, 2022
Record last verified: 2022-02
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