IMproving diagnosis and PRediction of Outcome in patients with seVEre Disorders Of Consciousness (IMPROVE-DOC)

IMproving diagnosis and PRediction of Outcome in patients with seVEre Disorders Of Consciousness (IMPROVE-DOC) - IMPROVE-DOC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51289

Enrollment

160

Registered

2022-12-05

Start date

2023-01-05

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Bewustzijnsstoornissen na ernstig hersenletsel Coma minimally conscious state (MCS) vegetative state/unresponsive wakefulness syndrome (VG/UWS)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients that are admitted to the ICU with the following criteria will be eligible for inclusion: 1. Severe brain injury (GCS = 18 years old 3. Written informed consent from legal representatives

Exclusion criteria

Exclusion criteria: - Absence of informed consent - Moribund at ICU admission - Progressive neurodegenerative disease - Pre-admission life expectancy 8 prior to inclusion - Impossible to include within 24 hours after brain injury

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the best neurological function and state of consciousness measured by the GOSE in 12 months.	—

Secondary

Measure	Time frame
The secondary outcomes are: The best neurological function and state of consciousness measured by the GOSE in 6 months. Level of consciousness measured with the SECONDs, weekly. Which type of EEG reactivity is most reliable in prediciting good neurological outcome.	—

Countries

Netherlands

Outcome results