Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
150
Countries
2
Sites
19
cardiopulmonary resuscitation
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.
Key facts
- Sponsor
- Universiteit Twente
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 10 Apr 2025 → ongoing
- Decision date (initial)
- 2025-03-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- ZonMw and KCE (BeNeFIT program)
External identifiers
- EU CT number
- 2024-516068-27-01
- ClinicalTrials.gov
- NCT06549426
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
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.
Secondary objectives 1
- To study the impact on healthcare costs of seizure suppression by stepwise anti-seizure treatment in comatose patients after cardiac arrest with ESE, as compared with no anti-seizure treatment.
Conditions and MedDRA coding
cardiopulmonary resuscitation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10058472 | Comatose | 10029205 |
| 20.0 | PT | 10007515 | Cardiac arrest | 100000004849 |
| 20.0 | PT | 10041962 | Status epilepticus | 100000004852 |
| 23.0 | LLT | 10083200 | Cardiopulmonary resuscitation | 10042613 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516068-27-00 | 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. | Universiteit Twente |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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
Exclusion criteria 8
- 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)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
Keppra 100 mg/ml concentrate for solution for infusion
PRD5267474 · Product
- Active substance
- Levetiracetam
- Substance synonyms
- S-ETIRACETAM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4500 mg milligram(s)
- Max total dose
- 189 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N03AX14 — LEVETIRACETAM
- Marketing authorisation
- EU/1/00/146/033
- MA holder
- UCB PHARMA S.A.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Esketiv 25 mg/ml, oplossing voor injectie
PRD7033666 · Product
- Active substance
- Esketamine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 240 mg/kg milligram(s)/kilogram
- Max total dose
- 10080 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX14 — ESKETAMINE
- Marketing authorisation
- RVG 121114
- MA holder
- EUROCEPT INTERNATIONAL BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Propofol 10 mg/ml MCT/LCT Fresenius emulsie voor injectie of infusie
PRD409194 · Product
- Active substance
- Propofol
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 120 mg/kg milligram(s)/kilogram
- Max total dose
- 5040 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- RVG 31762
- MA holder
- FRESENIUS KABI NEDERLAND B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Depakine i.v. 400, poeder voor injectievloeistof 400 mg
PRD2910850 · Product
- Active substance
- Sodium Valproate
- Substance synonyms
- VALPROATE SODIUM, Sodium Dipropylacetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 126 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N03AG01 — VALPROIC ACID
- Marketing authorisation
- RVG 14996
- MA holder
- SANOFI B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vimpat 10 mg/ml solution for infusion
PRD331924 · Product
- Active substance
- Lacosamide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 25.2 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N03AX18 — -
- Marketing authorisation
- EU/1/08/470/016
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Diazepam CF 5 mg/ml, oplossing voor injectie
PRD393831 · Product
- Active substance
- Diazepam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05BA01 — DIAZEPAM
- Marketing authorisation
- RVG 56691
- MA holder
- CENTRAFARM B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lorazepam Macure 4 mg/ml oplossing voor injectie
PRD7425729 · Product
- Active substance
- Lorazepam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05BA06 — LORAZEPAM
- Marketing authorisation
- RVG 122952
- MA holder
- MACURE PHARMA APS
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Midazolam Eugia 1 mg/ml, oplossing voor injectie/infusie of rectale toediening
PRD10854315 · Product
- Active substance
- Midazolam Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 96 mg/Kg milligram(s)/kilogram
- Max total dose
- 4032 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N05CD08 — MIDAZOLAM
- Marketing authorisation
- RVG 22594
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universiteit Twente
- Sponsor organisation
- Universiteit Twente
- Address
- Drienerlolaan 5
- City
- Enschede
- Postcode
- 7522 NB
- Country
- Netherlands
Scientific contact point
- Organisation
- Universiteit Twente
- Contact name
- prof.dr. J. Hofmeijer
Public contact point
- Organisation
- Universiteit Twente
- Contact name
- prof.dr. J. Hofmeijer
Locations
2 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 55 | 7 |
| Netherlands | Ongoing, recruiting | 95 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Intensive care, Avenue Max Buset 34, 7100, La Louviere
UZ Brussel
Intensive care, Laarbeeklaan 101, 1090, Jette
Hopital Erasme
Intensive care, Lennikse Baan 808, 1070, Anderlecht
CHC MontLegia
Neurology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Clinique Saint-Pierre
Intensive care, Avenue Reine Fabiola 9, 1340, Ottignies-Louvain-La-Neuve
CHU de Charleroi Hopital Civil Marie Curie
Intensive care, Chaussée de Bruxelles 140, 6042, Charleroi
Centre Hospitalier Universitaire De Liege
Neurophysiology, Avenue De L'hopital 1, 4000, Liege
Radboud universitair medisch centrum Stichting
Intensive care, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Maasstad Ziekenhuis Stichting
Neurology, Maasstadweg 21, 3079 DZ, Rotterdam
Amsterdam UMC Stichting
Neurology, Meibergdreef 9, 1105 AZ, Amsterdam
Canisius Wilhelmina Ziekenhuis
Neurology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Intensive care, Tegelseweg 210, 5912 BL, Venlo
Leids Universitair Medisch Centrum (LUMC)
Neurology, Albinusdreef 2, 2333 ZA, Leiden
Sint Antonius Ziekenhuis Stichting
Clinical neurophysiology, Koekoekslaan 1, 3435 CM, Nieuwegein
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Neurology and intensive care, Wytemaweg 80, 3015 CN, Rotterdam
Medisch Spectrum Twente
Neurology, Koningsplein 1, 7512 KZ, Enschede
Rijnstate Ziekenhuis Stichting
Neurology, Wagnerlaan 55, 6815 AD, Arnhem
Universitair Medisch Centrum Groningen
Neurophysiology, Hanzeplein 1, 9713 GZ, Groningen
Catharina Ziekenhuis Stichting
Neurology, Michelangelolaan 2, 5623 EJ, Eindhoven
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-07-25 | 2025-07-25 | |||
| Netherlands | 2025-04-10 | 2025-04-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 45 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-516068-27-00 | 1.2 |
| Protocol (for publication) | D1_Protocol_2024-516068-27-01_clean | 1.4 |
| Protocol (for publication) | D1_Protocol_2024-516068-27-01_TC | 1.4 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L Paper Interviewer Administration Dutch | 1 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L Paper Interviewer Administration French | 1 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L Paper Self-Complete Dutch | 1 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L Paper Self-Complete French | 1 |
| Protocol (for publication) | D4_Patient facing documents iMCQ Dutch | 1 |
| Protocol (for publication) | D4_Patient facing documents iPCQ Dutch | 1 |
| Protocol (for publication) | D4_Patient facing documents iPCQ French | 1 |
| Protocol (for publication) | D4_Patient facing documents MoCA Dutch | 1 |
| Protocol (for publication) | D4_Patient facing documents MoCA French | 1 |
| Protocol (for publication) | D4_Patient facing documents SF-36 Dutch | 1 |
| Protocol (for publication) | D4_Patient facing documents SF-36 French | 1 |
| Protocol (for publication) | D4_Patient facing documents_CPC score | 1 |
| Protocol (for publication) | D4_Patient facing documents_eGOS | 1 |
| Protocol (for publication) | D4_Patient facing documents_Modified Rankin Scale | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement v3_TC | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-00 Belgium_Dutch_for publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-00 Belgium_French_for publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-00 patient 2e instantie_Dutch_for publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-00 vertegenwoordiger_Dutch_for publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-00 vertegenwoordiger_Dutch_not for publication | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 Belgium_Dutch_for publication_ | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 Belgium_Dutch_for publication_clean | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 Belgium_French_for publication_ | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 Belgium_French_for publication_clean | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 patient 2e instantie_Dutch_for publication_TC | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 patient 2e instantie_Dutch_not for publication_TC | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 vertegenwoordiger_Dutch_for publication_TC | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 2024-516068-27-01 vertegenwoordiger_Dutch_not for publication_TC | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC diazepam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ketamine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC lacosamide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC levatiracetam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC lorazepam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC midazolam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC propofol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC valproic acid | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516068-27-00 Dutch | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516068-27-00 English | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516068-27-00 French | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-516068-27-00 German | 1.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-20 | Netherlands | Acceptable 2025-03-24
|
2025-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-02 | Netherlands | Acceptable 2025-05-26
|
2025-05-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-23 | Netherlands | Acceptable 2025-11-24
|
2025-11-24 |