Clinical trial • Not applicable • Cardiology

PROPOFOL for Cardiac arrest | Status epilepticus | Coma

Not applicable trial of PROPOFOL for Cardiac arrest | Status epilepticus | Coma.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Cardiac arrest | Status epilepticus | Coma
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-11-2024
First CTIS Authorization Date
25-03-2025

Trial design

Randomised, no anti-seizure treatment (control arm: no anti-seizure treatment), compared with stepwise anti-seizure treatment (intervention). Not applicable trial across 19 sites in Belgium, Netherlands.

Randomised
Yes
Comparator
No anti-seizure treatment (control arm: no anti-seizure treatment), compared with stepwise anti-seizure treatment (intervention).
Target Sample Size
150
Trial Duration For Participant
183

Eligibility

Recruits 150 Comatose patients are identified as a vulnerable population (isVulnerablePopulationSelected = true). Consent arrangements include subject information and informed consent forms for representatives and 'patient 2e instantie' (second-instance patient) in Dutch and French (documents L1_SIS and ICF for representative and patient 2e instantie are listed), indicating consent is to be obtained from legal/authorized representatives for incapacitated (comatose) participants..

Vulnerable Population
Comatose patients are identified as a vulnerable population (isVulnerablePopulationSelected = true). Consent arrangements include subject information and informed consent forms for representatives and 'patient 2e instantie' (second-instance patient) in Dutch and French (documents L1_SIS and ICF for representative and patient 2e instantie are listed), indicating consent is to be obtained from legal/authorized representatives for incapacitated (comatose) participants.

Inclusion criteria

  • {"criterion_text":"- Coma (Glasgow Coma Scale score ≤ 8) after out of hospital cardiac arrest and resuscitation"}
  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- Continuous EEG with at least eight electrodes started < 24h after return of spontaneous cir-culation (ROSC)"}
  • {"criterion_text":"- ESE or possible ESE according to the Salzburg and ACNS criteria"}
  • {"criterion_text":"- Possibility to start treatment within three hours after detection of ESE"}

Exclusion criteria

  • {"criterion_text":"- Known history of another medical condition with limited life expectancy (< six months)"}
  • {"criterion_text":"- Any progressive brain illness, such as a brain tumor or neurodegenerative disease"}
  • {"criterion_text":"- Pre-admission Glasgow Outcome Scale score of 3 or lower"}
  • {"criterion_text":"- Reason other than the neurological condition to withdraw treatment"}
  • {"criterion_text":"- EEG background activity prior to the emergence of ESE indicative of extensive irreversible anoxic brain injury"}
  • {"criterion_text":"- Follow-up impossible due to logistic reasons, for example not living in the Netherlands or Belgium"}
  • {"criterion_text":"- Insufficient understanding of the Dutch or French language."}
  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"eGOS at six months obtained by a standardized telephone interview by an independent investigator masked to treatment allocation and EEG pattern."}

Secondary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Health economic outcomes including QALYs, costs, ICER, ICER plane, and acceptability curve as part of cost-effectiveness analysis."}

Recruitment

Planned Sample Size
150
Recruitment Window Months
84
Consent Approach
Informed consent is arranged for incapacitated (comatose) participants via legal/authorized representatives. Subject information sheets and ICFs for representatives and for 'patient 2e instantie' (second-instance patient) are provided; documents are available in Dutch and French (multiple L1_SIS and ICF documents listed for Dutch and French).

Geography

Total Number Of Sites
19
Total Number Of Participants
150

Belgium

Earliest CTIS Part Ii Submission Date
05-03-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
310
Number Of Sites
7
Number Of Participants
55

Sites

Site Name
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Department Name
Intensive care
Contact Person Name
Y. Bouckaert
Contact Person Email
ybouckae@chu-tivoli.be
Site Name
Hopital Erasme
Department Name
Intensive care
Contact Person Name
F. Taccone
Contact Person Email
fabio.taccone@hubruxelles.be
Site Name
Clinique Saint-Pierre
Department Name
Intensive care
Contact Person Name
M. Vinetti
Contact Person Email
marco.vinetti@cspo.be
Site Name
Centre Hospitalier Universitaire De Liege
Department Name
Neurophysiology
Contact Person Name
O. Bodart
Contact Person Email
olivier.bodart@chuliege.be
Site Name
UZ Brussel
Department Name
Intensive care
Contact Person Name
R. van Lancker
Contact Person Email
Ruth.VanLancker@uzbrussel.be
Site Name
CHC MontLegia
Department Name
Neurology
Contact Person Name
B.M. Marx
Contact Person Email
barbara.marx@chc.be
Site Name
CHU de Charleroi Hopital Civil Marie Curie
Department Name
Intensive care
Contact Person Name
M. Piagnerelli
Contact Person Email
gwaelle.ducomble@chuliege.be

Netherlands

Earliest CTIS Part Ii Submission Date
25-02-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
272
Number Of Sites
12
Number Of Participants
95

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Intensive care
Contact Person Name
A. Hoedemaekers
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Neurology
Contact Person Name
S.C. Tromp
Contact Person Email
s.c.tromp@lumc.nl
Site Name
Maasstad Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
W. Moudrous
Site Name
Catharina Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
M. van Eijck
Site Name
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Department Name
Intensive care
Contact Person Name
N. Foudraine
Contact Person Email
nfoudraine@viecuri.nl
Site Name
Medisch Spectrum Twente
Department Name
Neurology
Contact Person Name
B. Beishuizen
Contact Person Email
researchIC@mst.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Neurophysiology
Contact Person Name
G. Drost
Contact Person Email
g.drost@umcg.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
Neurology
Contact Person Name
F. Nijhuis
Contact Person Email
f.nijhuis@cwz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Neurology and intensive care
Contact Person Name
M. van der Jagt
Contact Person Email
m.vanderjagt@erasmusmc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Neurology
Contact Person Name
J. Horn
Contact Person Email
j.horn@amsterdamumc.nl
Site Name
Sint Antonius Ziekenhuis Stichting
Department Name
Clinical neurophysiology
Contact Person Name
L. Wieske
Contact Person Email
l.wieske@antoniusziekenhuis.nl
Site Name
Rijnstate Ziekenhuis Stichting
Department Name
Neurology
Contact Person Name
J. Hofmeijer
Contact Person Email
jhofmeijer@rijnstate.nl

Sponsor

Primary sponsor

Full Name
Universiteit Twente
Organisation Type
Educational Institution
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Propofol 10 mg/ml MCT/LCT Fresenius emulsie voor injectie of infusie
Active Substance
PROPOFOL
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 120 mg/kg; Max total dose: 5040 mg/kg
Investigational Product Name
Diazepam CF 5 mg/ml, oplossing voor injectie
Active Substance
DIAZEPAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 20 mg; Max total dose: 20 mg
Investigational Product Name
Esketiv 25 mg/ml, oplossing voor injectie
Active Substance
ESKETAMINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 240 mg/kg; Max total dose: 10080 mg/kg
Investigational Product Name
Lorazepam Macure 4 mg/ml oplossing voor injectie
Active Substance
LORAZEPAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 4 mg; Max total dose: 4 mg
Investigational Product Name
Depakine i.v. 400, poeder voor injectievloeistof 400 mg
Active Substance
SODIUM VALPROATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 3000 mg; Max total dose: 126 g
Investigational Product Name
Keppra 100 mg/ml concentrate for solution for infusion
Active Substance
LEVETIRACETAM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 4500 mg; Max total dose: 189 g
Investigational Product Name
Vimpat 10 mg/ml solution for infusion
Active Substance
LACOSAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 600 mg; Max total dose: 25.2 g
Investigational Product Name
Midazolam Eugia 1 mg/ml, oplossing voor injectie/infusie of rectale toediening
Active Substance
MIDAZOLAM HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
Max daily dose: 96 mg/kg; Max total dose: 4032 mg/kg
Combination Treatment
Yes

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