S-ketamine for cortical spreading depolarisation in patients with severe acute brain injury (KETA-BID trial)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515315-22-00

Acronym

RHNIA-001-2021

Enrollment

400

Registered

2024-09-12

Start date

2023-09-15

Completion date

Unknown

Last updated

2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury

Brief summary

Occurrence of cortical spreading depolarisations per hour of monitoring after randomisation

Detailed description

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

Interventions

DRUGSODIUM CHLORIDE

DRUGESKETAMINE HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of cortical spreading depolarisations per hour of monitoring after randomisation	—

Secondary

Measure	Time frame
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	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026