Overview
Sponsor-declared trial summary
subarachnoid hemorrhage, intracerebral hemorrhage, traumatic brain injury
This pilot and feasibility trial – the KETA-BID trial – aims to investigate the efficacy and safety of S-ketamine on the occurrence of SDs and the feasibility of the setup. More specifically, the KETABID trial investigates the efficacy of S-ketamine in patients in whom SDs persist despite physiological optimisation.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 15 Sep 2023 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Sundhedsdonationer (2024-0378) · An open grant from the Research Board at Rigshospitalet · The A.P. Møller Foundation (Fonden til Lægevidenskabens Fremme, 20-L-0041) · The Danish Victims’ Foundation (20-610-00103) · The Novo Nordisk Foundation (NNF20OC0065750) · Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond · Research Fund at Department of Neurosurgery Rigshospitalet · Dagmar Marshall Foundation · Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond · A 3-year PhD grant from the Research Board at Rigshospitalet · Knud and Edith Eriksens Mindefond (62786-2021) · Læge Sofus Carl Emil Friis og hustru Olga Doris Friis legat · Danish Society for Anaesthesiology and Intensive Care Medicine (DASAIM) Research Initiative 2021
External identifiers
- EU CT number
- 2024-515315-22-00
- EudraCT number
- 2021-003716-12
- ClinicalTrials.gov
- NCT05095857
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Safety, Efficacy
This pilot and feasibility trial – the KETA-BID trial – aims to investigate the efficacy and safety of S-ketamine on the occurrence of SDs and the feasibility of the setup. More specifically, the KETABID
trial investigates the efficacy of S-ketamine in patients in whom SDs persist despite physiological optimisation.
Secondary objectives 1
- The secondary objectives of this trial is investigate the safety of using S-ketamine for patients with severe acute brain injury by investigating the rate of adverse events and adverse reactions after randomisation and throughout the intervention period, and to examine functional outcome at 6 months after ictus of brain injury
Conditions and MedDRA coding
subarachnoid hemorrhage, intracerebral hemorrhage, traumatic brain injury
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10019529 | Hemorrhage brain | 10029205 |
| 21.1 | LLT | 10018061 | General anesthesia | 10042613 |
| 21.1 | LLT | 10070731 | Electrocorticography | 10042613 |
| 20.0 | LLT | 10056389 | Brain damage | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age ≥ 18 years
- Admitted to the Neurointensive Care Unit with a diagnosis of traumatic brain injury, aneurysmal subarachnoid hemorrhage or spontaneous intracerebral hemorrhage
- Planned for surgery with a supratentorial craniotomy or craniectomy
- Expected to continue sedation and mechanical ventilation after surgery
Exclusion criteria 8
- Neither patient or next of kin understand Danish or English
- Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients)
- Wake-up call to occur immediately after surgery
- Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG to control for pregnancy)
- Active anti-psychotic treatment before admission
- Current abuse of ketamine
- Decision to withdraw active treatment
- Intracerebral hemorrhage secondary to a known brain tumour at the time of inclusion.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of cortical spreading depolarisations per hour of monitoring after randomisation
Secondary endpoints 2
- Rate of adverse events and adverse reactions after randomisation and throughout the intervention period
- Functional outcome (using modified Rankin Scale and Glasgow Outcome Scale-Extended) at 6 months after randomisation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB25811 · Substance
- Active substance
- Esketamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 3 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 984 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2.88 millilitre(s)/kilogram
- Max total dose
- 39.4 millilitre(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Kirsten Møller
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Trine Hjorslev Andreasen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 400 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2023-09-15 | 2023-09-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol public version_2024-515315-22-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment procedure_2024-515315-22-00 | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_nextofkin_KETA-BID_DA | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_participant_KETA-BID_DA | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_trialguardian_KETA-BID_DA | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_Nextofkin KETA-BID_DA | 5 |
| Subject information and informed consent form (for publication) | L1_SIS_Participant KETA-BID_DA | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC S-ketamine_DA | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-23 | Denmark | Acceptable 2024-09-12
|
2024-09-12 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-25 | Denmark | Acceptable 2024-09-12
|
2025-03-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-25 | Denmark | Acceptable 2024-09-12
|
2025-03-25 |