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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on improving the way doctors diagnose and predict outcomes for patients who have suffered severe brain injuries, such as from traumatic brain injuries, strokes, or infections. Many of these patients may experience disorders of consciousness, meaning they may not respond or be aware of their surroundings after sedation is stopped. The goal of the study is to better identify which patients have a chance of recovery so that treatment decisions can be made more accurately, especially regarding life-sustaining support.

To participate in the trial, patients must be at least 18 years old and have a severe brain injury that results in a low score on a common assessment scale (known as GCS, or Glasgow Coma Scale). They must also be admitted to the Intensive Care Unit (ICU) and have informed consent provided by their legal representatives. The study is currently recruiting participants, and those who join can expect close monitoring and assessments that could help improve future care for similar patients. Importantly, the trial aims to gather valuable information that could lead to better outcomes for others facing similar health challenges.

Gender

ALL

Eligibility 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