Traumatic Brain InjuryIMPROVE-DOCNCT06283901
Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
An observational study of Traumatic Brain Injury and Intracranial Hemorrhages, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hemorrhages, Subarachnoid Hemorrhage
- How many people
- 160 participants
- Where
- 5 sitesNetherlands
- Study dates
- 2 Jan 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients with acute severe brain injury admitted to the ICU of at least 18 years old.
Who may be able to join
- All patients that are admitted to the ICU with the following criteria will be eligible for inclusion:
- Severe brain injury (GCS ≤ 8) as a result of:
- Traumatic brain injury
- Ischemic cerebrovascular accident
- Intracranial hemorrhage
- Meningo-encephalitis
Show all 9Show fewer
- Subarachnoid hemorrhage
- Age ≥ 18 years old
- Written informed consent from legal representatives
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
Janneke Horn, Prof. dr. contact
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Wolmet Haksteen, MD, +31 020 - 566 9111, w.e.haksteen@amsterdamumc.nl
- Not yet recruiting
UMC Groningen
Groningen, 9713 GZ
Joukje van der Naalt
- Recruiting
Radboud UMC
Nijmegen, Gelderland, 6525 GA
Astrid Hoedemaekers
- Not yet recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Mathieu van der Jagt
- Recruiting
Haaglanden MC, locatie Westeinde
The Hague, South Holland, 2512 VA
Sefanja Achterberg
About this study
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.
Read the detailed description
In order to identify patients with a good neurological outcome a combination of diagnostic tests is used.
Clinical rating scales
- Simplified evaluation of consciousness scale (SECONDs) and the full outline of unresponsiveness (FOUR) score
- Once a week
Blood biomarkers
- Neuron specific enolase, neurofilament light, glial fibrillary acidic protein
- Sampling timepoints: 24h, 72h, 7 days and 14 days after brain injury
- Serum (STG-5) and plasma (EDTA-6) tubes, aliquoted (4 x 0.5ml) and stored at -80°C
EEG with reactivity testing
- Standard 21-electrode montage
- Stimuli protocol I: a set of 5 stimuli repeated 3 times
- Auditory: clapping in hands, 2. Auditory: calling patients name loudly, 3. Visual: passive eye opening, 4. Tactile: nasal tickle, 5. Noxious: sternal rub Each stimuli is applied for a duration of 5 seconds and an interval between stimuli of 30 seconds
- Stimuli protocol II: Cognitive-motor dissociation test
MRI-scan
- Sequences considered essential for patient care i.e.T1, T2, FLAIR, DWI/SWI
- Preferably, performed between 4-6 weeks after hospital admission
- Conditions
- Traumatic Brain Injury, Intracranial Hemorrhages, Subarachnoid Hemorrhage, Meningitis, Encephalitis, Stroke
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hemorrhages, Subarachnoid Hemorrhage, Meningitis, Encephalitis, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale Extended
Measured: 6 months
Secondary outcomes (1)
Glasgow Outcome Scale Extended
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start2 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Janneke Horn, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283901
- Sponsor's protocol ID
- NL82013.018.22
- Acronym
- IMPROVE-DOC
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06283901
- Acronym / sponsor ID
- IMPROVE-DOC / NL82013.018.22
- Conditions
- Traumatic Brain Injury, Intracranial Hemorrhages, Subarachnoid Hemorrhage, Meningitis, Encephalitis, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to identify patients with a good neurological outcome a combination of diagnostic tests is used.
Clinical rating scales
- Simplified evaluation of consciousness scale (SECONDs) and the full outline of unresponsiveness (FOUR) score
- Once a week
Blood biomarkers
- Neuron specific enolase, neurofilament light, glial fibrillary acidic protein
- Sampling timepoints: 24h, 72h, 7 days and 14 days after brain injury
- Serum (STG-5) and plasma (EDTA-6) tubes, aliquoted (4 x 0.5ml) and stored at -80°C
EEG with reactivity testing
- Standard 21-electrode montage
- Stimuli protocol I: a set of 5 stimuli repeated 3 times
- Auditory: clapping in hands, 2. Auditory: calling patients name loudly, 3. Visual: passive eye opening, 4. Tactile: nasal tickle, 5. Noxious: sternal rub Each stimuli is applied for a duration of 5 seconds and an interval between stimuli of 30 seconds
- Stimuli protocol II: Cognitive-motor dissociation test
MRI-scan
- Sequences considered essential for patient care i.e.T1, T2, FLAIR, DWI/SWI
- Preferably, performed between 4-6 weeks after hospital admission
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with acute severe brain injury admitted to the ICU of at least 18 years old.
Key inclusion criteria (9 listed)
- All patients that are admitted to the ICU with the following criteria will be eligible for inclusion:
- Severe brain injury (GCS ≤ 8) as a result of:
- Age ≥ 18 years old
- Written informed consent from legal representatives
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow Outcome Scale Extended
Time frame: 6 months
1 secondary outcome
Glasgow Outcome Scale Extended
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janneke Horn, Prof. dr. contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Intracranial Hemorrhages, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolmet Haksteen, MD (+31 020 566 9111, w.e.haksteen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Extended (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.