Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness

NCT06283901 | Recruiting

• 1 other identifier: NL82013.018.22
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 5

Brief Summary

Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.

Conditions

Traumatic Brain Injury; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Meningitis; Encephalitis; Stroke

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale Extended

  6 months

Secondary Outcomes (1)

• Glasgow Outcome Scale Extended

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with acute severe brain injury admitted to the ICU of at least 18 years old.

You may qualify if:

• Severe brain injury (GCS ≤ 8) as a result of:
• Traumatic brain injury
• Ischemic cerebrovascular accident
• Intracranial hemorrhage
• Meningo-encephalitis
• Subarachnoid hemorrhage
• Age ≥ 18 years old
• Written informed consent from legal representatives

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Absence of informed consent
• Moribund at ICU admission
• Progressive neurodegenerative disease
• Pre-admission life expectancy ≤ 6 months based on comorbidity
• Impossible to include within 24 hours after brain injury

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (5)

Radboud UMC

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

Haaglanden MC, locatie Westeinde

The Hague, South Holland, 2512 VA, Netherlands

RECRUITING

UMC Groningen

Groningen, 9713 GZ, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Meningitis; Encephalitis; Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases

Central Study Contacts

Wolmet Haksteen, MD

CONTACT

+31 020 566 9111; w.e.haksteen@amsterdamumc.nl

Janneke Horn, Prof. dr.

CONTACT

j.horn@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. J. Horn

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: January 2, 2023
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

NL (5)