Clinical trial • Neurology
KETAMINE for Traumatic brain injury
Clinical trial of KETAMINE for Traumatic brain injury.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Traumatic brain injury
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 29-01-2024
- First CTIS Authorization Date
- 21-02-2024
Trial design
Randomised, test: ketalar 50 mg/ml solution injectable (ketamine) administered by intravenous infusion; dose unit listed as mg/kg/h with max daily dose amount 1 mg/kg/h and max total dose amount 120 mg/h (max treatment period 4 [time unit code provided]). comparator/placebo: 0,9% nacl (placebo) intravenous infusion. exact dosing schedule for ketamine (starting dose, titration) not specified in provided data.-controlled trial in Belgium.
- Randomised
- Yes
- Comparator
- Test: Ketalar 50 mg/ml solution injectable (ketamine) administered by intravenous infusion; dose unit listed as mg/kg/h with max daily dose amount 1 mg/kg/h and max total dose amount 120 mg/h (max treatment period 4 [time unit code provided]). Comparator/placebo: 0,9% NaCl (placebo) intravenous infusion. Exact dosing schedule for ketamine (starting dose, titration) not specified in provided data.
- Target Sample Size
- 100
Eligibility
Recruits 100 Vulnerable population selected. The dossier indicates 'isVulnerablePopulationSelected': true and lists 'Inability to obtain informed consent' as an exclusion. No further details on consent/assent handling or age-specific consent documents are provided in the available files..
- Pregnancy Exclusion
- Known pregnancy and/or lactation
- Vulnerable Population
- Vulnerable population selected. The dossier indicates 'isVulnerablePopulationSelected': true and lists 'Inability to obtain informed consent' as an exclusion. No further details on consent/assent handling or age-specific consent documents are provided in the available files.
Inclusion criteria
- {"criterion_text":"- Traumatic brain injury"}
- {"criterion_text":"- Age ≥ 18 years"}
- {"criterion_text":"- Admitted to the Intensive Care Unit"}
- {"criterion_text":"- Within 72 hours after admission to the initial hospital: ICP monitor in place (parenchymal probe, ventricular catheter, or both) and requiring sedation"}
Exclusion criteria
- {"criterion_text":"- Known pregnancy and/or lactation"}
- {"criterion_text":"- Imminent or actual brain death upon inclusion"}
- {"criterion_text":"- Allergy or intolerance to the study medication"}
- {"criterion_text":"- Pre-existing neurocognitive disorders, pre-existing congenital or non-congenital brain dysfunction."}
- {"criterion_text":"- Inability to obtain informed consent"}
- {"criterion_text":"- Inclusion in an IMP-RCT of which the PI indicates that co-inclusion specifically in the BIKe study is prohibited"}
- {"criterion_text":"- Therapy restriction code upon inclusion"}
- {"criterion_text":"- Porphyria"}
- {"criterion_text":"- Glaucoma"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Reduction in cumulative daily TIL score.","definition_or_measurement_approach":""}
- {"endpoint_text":"- The number of high intracranial pressure episodes defined as an ICP >22 mmHg for >25 minutes","definition_or_measurement_approach":"High ICP episode defined as ICP >22 mmHg for >25 minutes"}
Secondary endpoints
- {"endpoint_text":"- The average intracranial pressure (mmHg) per 24h","definition_or_measurement_approach":""}
- {"endpoint_text":"- Total duration of the first episode of sedative treatment (hours)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Total duration of the first episode of mechanical ventilation","definition_or_measurement_approach":""}
- {"endpoint_text":"- Total dose of propofol in mg per 24 hours","definition_or_measurement_approach":""}
- {"endpoint_text":"- Total dose of midazolam in mg per 24 hours","definition_or_measurement_approach":""}
- {"endpoint_text":"- Length of stay in the Intensive Care Unit (ICU)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Length of stay in the hospital (days)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Average daily Richmond agitation and sedation score (RASS) (addendum 2) per hour","definition_or_measurement_approach":""}
- {"endpoint_text":"- Delirium-free days, defined with the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method-ICU (CAM-ICU) every 8 hours (ICDSC)","definition_or_measurement_approach":"Delirium-free days defined using ICDSC or CAM-ICU assessments every 8 hours (ICDSC)"}
- {"endpoint_text":"- Extended Glasgow Outcome Score (GOSE) at 6 months after the onset of brain injury","definition_or_measurement_approach":"GOSE measured at 6 months after onset of brain injury"}
- {"endpoint_text":"- The incidence of barbiturate coma","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of decompressive craniectomy","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence of Propofol-Related Infusion Syndrome (PRIS)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 70
- Consent Approach
- Informed consent is required; 'Inability to obtain informed consent' is listed as an exclusion criterion. No further details on the consent or assent process (who provides consent, age-specific documents, or languages available) are provided in the available records.
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 100
Belgium
- Earliest CTIS Part Ii Submission Date
- 07-02-2024
- Latest Decision Or Authorization Date
- 21-02-2024
- Processing Time Days
- 14
- Number Of Sites
- 8
- Number Of Participants
- 100
Sites
- Site Name
- Imelda
- Department Name
- Intensive Care Medicine
- Principal Investigator Name
- Emmanuel Van Der Hauwaert
- Principal Investigator Email
- emmanuel.Van.der.hauwaert@imelda.be
- Contact Person Name
- Emmanuel Van Der Hauwaert
- Contact Person Email
- emmanuel.Van.der.hauwaert@imelda.be
- Site Name
- AZ Turnhout
- Department Name
- Intensive Care Medicine
- Principal Investigator Name
- Eva Boonen
- Principal Investigator Email
- eva.boonen@azturnhout.be
- Contact Person Name
- Eva Boonen
- Contact Person Email
- eva.boonen@azturnhout.be
- Site Name
- CHU De Liege
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Didier Ledoux
- Principal Investigator Email
- dledoux@chuliege.be
- Contact Person Name
- Didier Ledoux
- Contact Person Email
- dledoux@chuliege.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- Intensive Care Unit
- Principal Investigator Name
- Hugues Maréchal
- Principal Investigator Email
- Hugues.marechal@chrcitadelle.be
- Contact Person Name
- Hugues Maréchal
- Contact Person Email
- Hugues.marechal@chrcitadelle.be
- Site Name
- UZ Leuven
- Department Name
- Intensive Care Medicine
- Principal Investigator Name
- Geert Meyfroidt
- Principal Investigator Email
- geert.meyfroidt@uzleuven.be
- Contact Person Name
- Geert Meyfroidt
- Contact Person Email
- geert.meyfroidt@uzleuven.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Anesthesia and Critical Care
- Principal Investigator Name
- Marc Bourgeois
- Principal Investigator Email
- Marc.bourgeois@azsintjan.be
- Contact Person Name
- Marc Bourgeois
- Contact Person Email
- Marc.bourgeois@azsintjan.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Intensive care medicine
- Principal Investigator Name
- Jasperina Dubois
- Principal Investigator Email
- info@jessazh.be
- Contact Person Name
- Jasperina Dubois
- Contact Person Email
- info@jessazh.be
- Site Name
- Az Delta
- Department Name
- Intensive Care Medicine
- Principal Investigator Name
- Piet Lormans
- Principal Investigator Email
- Piet.Lormans@azdelta.be
- Contact Person Name
- Piet Lormans
- Contact Person Email
- Piet.Lormans@azdelta.be
Sponsor
Primary sponsor
- Full Name
- UZ Leuven
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Third parties
- {"country":"Belgium","full_name":"Pfizer Belgium","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Ketalar 50 mg/ml solution injectable
- Active Substance
- KETAMINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Marketing authorisation BE005293 (authorised)
- Maximum Dose
- 1 mg/kg/h (max total 120 mg/h)
- Investigational Product Name
- 0,9% NaCl
- Modality
- Other
- Combination Treatment
- Yes
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