Improving diagnosis and prediction of outcomes in patients with severe brain injuries
Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06283901
This study is trying to find better ways to predict recovery in patients with severe brain injuries by using tests like blood samples and brain scans to help doctors make informed decisions about their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 5 sites (Nijmegen, Gelderland and 4 other locations) |
| Trial ID | NCT06283901 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with acute severe brain injuries who may experience disorders of consciousness after sedation. It aims to improve the prediction of neurological outcomes using a combination of clinical rating scales, blood biomarkers, EEG reactivity testing, and MRI scans. Patients will be assessed weekly and at various time points post-injury to identify those with a potential for good recovery. The goal is to enhance decision-making regarding life-sustaining treatments based on reliable diagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe brain injuries resulting in a Glasgow Coma Scale score of 8 or less.
Not a fit: Patients who are moribund at ICU admission or have progressive neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients who may recover, thereby informing treatment decisions and potentially improving quality of life.
How similar studies have performed: While similar approaches have been explored, this study employs a novel combination of diagnostic tests to enhance outcome prediction in severe brain injury cases.
Eligibility criteria
Show full inclusion / exclusion 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 ≤ 8) as a result of: 1. Traumatic brain injury 2. Ischemic cerebrovascular accident 3. Intracranial hemorrhage 4. Meningo-encephalitis 5. Subarachnoid hemorrhage 2. Age ≥ 18 years old 3. Written informed consent from legal representatives Exclusion Criteria: 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 * GCS has been \> 8 prior to inclusion * Impossible to include within 24 hours after brain injury
Where this trial is running
Nijmegen, Gelderland and 4 other locations
- Radboud UMC — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
- Haaglanden MC, locatie Westeinde — Den Haag, Zuid-Holland, Netherlands (RECRUITING)
- Erasmus MC — Rotterdam, Zuid-Holland, Netherlands (NOT_YET_RECRUITING)
- UMC Groningen — Groningen, Netherlands (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Wolmet Haksteen, MD
- Email: w.e.haksteen@amsterdamumc.nl
- Phone: +31 020 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Traumatic Brain Injury, Intracranial Hemorrhages, Subarachnoid Hemorrhage, Meningitis, Encephalitis, Stroke