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NCT05095857: KETA-BID
The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
Phase 4 trial testing S-ketamine in Subarachnoid Hemorrhage, Aneurysmal in 400 participants. Currently enrolling.
15 September 2028
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 15 September 2023 |
| Primary completion | 15 September 2028 |
| Estimated completion | 15 September 2028 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- S-ketamine
- Isotonic saline (placebo)
Conditions studied
- Subarachnoid Hemorrhage, Aneurysmal — all drugs for Subarachnoid Hemorrhage, Aneurysmal →
- Intracerebral Hemorrhage — all drugs for Intracerebral Hemorrhage →
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
Sponsor
Rigshospitalet, Denmark
Who can join
18 and older, any sex, with Subarachnoid Hemorrhage, Aneurysmal or Intracerebral Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cortical spreading depolarisations are pathological depolarisation waves that occur frequently after severe acute brain injury and has been associated with poor outcome. S-ketamine has been shown to inhibit cortical spreading depolarisations. The aim of the present study is to examine the efficacy and safety of using S-ketamine for treatment of patients with severe acute brain injury, as well as the feasibility of the trial design.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05095857
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT05242692 — The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-c · EARLY_PHASE1 · completed
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Other recruiting trials for Subarachnoid Hemorrhage, Aneurysmal
Currently open trials in the same condition.
- NCT04696523 — Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage · Phase 2 · recruiting
- NCT06819657 — Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid H · NA · recruiting
- NCT06766422 — AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction · recruiting
- NCT06906432 — Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage · recruiting
- NCT06218654 — Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage · recruiting
Other Rigshospitalet, Denmark trials
Trials by the same sponsor.
- NCT07401368 — Clinicians' Trust in AI-Based Fetal Growth Estimates · NA · not yet recruiting
- NCT07442357 — The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial · NA · not yet recruiting
- NCT07528729 — Alcohol as a Modifiable Risk Factor for Atrial Fibrillation · NA · not yet recruiting
- NCT07511439 — Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission · Phase 4 · not yet recruiting
- NCT07467187 — Invasive Home Ventilation in Denmark · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05095857 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
- Last refreshed: 26 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05095857.
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