Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283901
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-22
Brief Title:
Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE-DOC
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CT-brain imaging Reliable identification of patients with a possible good outcome in whom treatment should not be withdrawn is difficult In this prospective observational cohort study we aim to identify patients with a good neurological outcome
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 05ml and stored at -80C
EEG with reactivity testing
Standard 21-electrode montage
Stimuli protocol I a set of 5 stimuli repeated 3 times
1 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 ieT1 T2 FLAIR DWISWI
Preferably performed between 4-6 weeks after hospital admission
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 05ml and stored at -80C
EEG with reactivity testing
Standard 21-electrode montage
Stimuli protocol I a set of 5 stimuli repeated 3 times
1 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 ieT1 T2 FLAIR DWISWI
Preferably performed between 4-6 weeks after hospital admission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None