Clinical trial • Neurology

ESKETAMINE HYDROCHLORIDE for Subarachnoid hemorrhage | Intracerebral hemorrhage | Traumatic brain injury

Clinical trial of ESKETAMINE HYDROCHLORIDE for Subarachnoid hemorrhage | Intracerebral hemorrhage | Traumatic brain injury.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Subarachnoid hemorrhage | Intracerebral hemorrhage | Traumatic brain injury
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-08-2024
First CTIS Authorization Date
12-09-2024

Trial design

Randomised, sodium chloride (placebo) infusion (isotonic saline). dose units recorded as millilitre(s)/kilogram with max daily dose amount 2.88 ml/kg and max total dose amount 39.4 ml/kg; route: infusion.-controlled trial across 1 site in Denmark.

Randomised
Yes
Comparator
SODIUM CHLORIDE (placebo) infusion (isotonic saline). Dose units recorded as millilitre(s)/kilogram with max daily dose amount 2.88 mL/kg and max total dose amount 39.4 mL/kg; route: infusion.
Target Sample Size
400
Trial Duration For Participant
183

Eligibility

Recruits 400 Vulnerable adult patients with severe acute brain injury are included (isVulnerablePopulationSelected = true). The trial provides separate informed consent documents for participants, next of kin and trial guardian (documents present: L1_ICF_participant, L1_ICF_nextofkin, L1_ICF_trialguardian and SIS versions). When participants lack capacity, consent is obtained from next of kin or a trial guardian using the dedicated ICFs (documents available in Danish)..

Pregnancy Exclusion
Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG to control for pregnancy)
Vulnerable Population
Vulnerable adult patients with severe acute brain injury are included (isVulnerablePopulationSelected = true). The trial provides separate informed consent documents for participants, next of kin and trial guardian (documents present: L1_ICF_participant, L1_ICF_nextofkin, L1_ICF_trialguardian and SIS versions). When participants lack capacity, consent is obtained from next of kin or a trial guardian using the dedicated ICFs (documents available in Danish).

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years\n- Admitted to the Neurointensive Care Unit with a diagnosis of traumatic brain injury, aneurysmal subarachnoid hemorrhage or spontaneous intracerebral hemorrhage\n- Planned for surgery with a supratentorial craniotomy or craniectomy\n- Expected to continue sedation and mechanical ventilation after surgery"}

Exclusion criteria

  • {"criterion_text":"- Neither patient or next of kin understand Danish or English\n- Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients)\n- Wake-up call to occur immediately after surgery\n- Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG to control for pregnancy)\n- Active anti-psychotic treatment before admission\n- Current abuse of ketamine\n- Decision to withdraw active treatment\n- Intracerebral hemorrhage secondary to a known brain tumour at the time of inclusion."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Occurrence of cortical spreading depolarisations per hour of monitoring after randomisation","definition_or_measurement_approach":"Measured as the number (occurrence) of cortical spreading depolarisations per hour of monitoring after randomisation (per protocol monitoring period after randomisation)."}

Secondary endpoints

  • {"endpoint_text":"- Rate of adverse events and adverse reactions after randomisation and throughout the intervention period","definition_or_measurement_approach":"Measured as the rate/frequency of adverse events and adverse reactions occurring after randomisation and during the intervention period."}
  • {"endpoint_text":"- Functional outcome (using modified Rankin Scale and Glasgow Outcome Scale-Extended) at 6 months after randomisation","definition_or_measurement_approach":"Measured using the modified Rankin Scale (mRS) and the Glasgow Outcome Scale-Extended (GOSE) at 6 months after randomisation."}

Recruitment

Planned Sample Size
400
Recruitment Window Months
60
Consent Approach
Participants are adults (Age ≥ 18). Informed consent documents exist for participants, next of kin and trial guardian (L1_ICF_participant, L1_ICF_nextofkin, L1_ICF_trialguardian and SIS versions). For participants lacking capacity due to severe acute brain injury, consent is obtained from next of kin or a trial guardian using the dedicated ICFs. Documents available in Danish (DA).

Geography

Total Number Of Sites
1
Total Number Of Participants
400

Denmark

Earliest CTIS Part Ii Submission Date
30-08-2024
Latest Decision Or Authorization Date
25-03-2025
Processing Time Days
207
Number Of Sites
1
Number Of Participants
400

Sites

Site Name
Rigshospitalet
Department Name
Department of Neurosurgery
Contact Person Name
Trine Hjorslev Andreasen

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
ESKETAMINE HYDROCHLORIDE
Active Substance
ESKETAMINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Frequency
continuous infusion (dose unit mg/kg/h)
Maximum Dose
3 mg/kg/h (max daily dose); max total amount 984 mg
Investigational Product Name
SODIUM CHLORIDE
Active Substance
SODIUM CHLORIDE
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Frequency
as infusion (dose unit mL/kg)
Maximum Dose
2.88 mL/kg daily (max); max total amount 39.4 mL/kg

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