WithdrawnNot Applicable

Cognitive Function and Health-related Quality of Life After Neuro-intensive Care

Stopped: Primary Investigator ceased their involvement with study

0Started 2021-08-01

Plain-language summary

The study will provide information on cognitive impairment and Health related quality of life in patients surviving 12 months after acute brain injury, generate a hypothesis of useful variables to predict cognitive impairment or low levels of HRQoL, and potentially inform interventions for the prevention and treatment of cognitive impairment following neuro-ICU stay.

Who can participate

Age range

18 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Traumatic brain injury * Spontaneous intracranial hemorrhage * Ischemic stroke * An anticipated stay in the neuro-ICU for 48 hours or longer. Exclusion Criteria: * Persistent coma defined as Richmond Agitation-Sedation Scale (RASS) -5 to -3 throughout the neuro-ICU stay * Congenital brain injury * Suspected pre-existing Cognitive impairment (Informant Questionnaire on cognitive decline in the elderly (IQCODE): 3.3 or more) (regardless of cause) * Permanent residence outside Denmark * Inability to communicate in Danish

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Global cognitive function

Timeframe: from baseline to 6 months after ICU admission

Change in Global cognitive function

Timeframe: from baseline to 12 months after ICU admission

Change in Executive function

Timeframe: from baseline to 6 months after ICU admission

Change in Executive function

Timeframe: from baseline to 12 months after ICU admission

Trial details

NCT IDNCT04881097

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-01

View on ClinicalTrials.gov More Acute Brain Injury trials

Plain-language summary

Who can participate

Age range

18 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Global cognitive function

Timeframe: from baseline to 6 months after ICU admission

Change in Global cognitive function

Timeframe: from baseline to 12 months after ICU admission

Change in Executive function

Timeframe: from baseline to 6 months after ICU admission

Change in Executive function

Timeframe: from baseline to 12 months after ICU admission