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

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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 Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult.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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

∙ 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

⁃ Subarachnoid hemorrhage

• Age ≥ 18 years old

• Written informed consent from legal representatives

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
UMC Groningen
NOT_YET_RECRUITING
Groningen
Radboud UMC
RECRUITING
Nijmegen
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Haaglanden MC, locatie Westeinde
RECRUITING
The Hague
Contact Information
Primary
Wolmet Haksteen, MD
w.e.haksteen@amsterdamumc.nl
+31 020 566 9111
Backup
Janneke Horn, Prof. dr.
j.horn@amsterdamumc.nl
Time Frame
Start Date: 2023-01-02
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 160
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov