Department of Neurology - Ghent University Hospital
Ghent, Flanders, 9000, Belgium
Location status: Recruiting
NCT Number: NCT04956185
The purpose of this prospective observational study is to create a database in which data will be collected from every patient admitted to the Stroke unit and who has explicitly given his or her informed consent for this data collection. The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.
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Observational
Ghent, Flanders, 9000, Belgium
Location status: Recruiting
Every patient that is admitted to the Stroke unit will be asked if his or her data and relevant personal information can be registered in a database with the purpose of conducting research in the future. If he or she agrees, one of the researchers will go through the Informed Consent Form together with the patient. If the patient has questions, the researcher will answer them. If the patient then agrees to the data collection, he or she will sign the Informed Consent Form.
The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. We will collect the following data:
The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: date of inclusion until end of follow-up (12 months)
Information about patients included in the stroke database: age, gender, medical/family history
Time frame: date of inclusiondate of inclusion until end of follow-up (12 months)
Time between stroke onset and arrival at Emergency Department
Time frame: date of inclusion until end of follow-up (12 months)
Patients treated with acute stroke therapy (i.e. thrombolysis and/or thrombectomy), start time of acute therapy
Time frame: date of inclusion until end of follow-up (12 months)
Outcome after acute therapy, assessed by NIHSS and mRS score, possible complications and imaging
Time frame: date of inclusion until end of follow-up (12 months)
Incidence of neurological complications, epilepsy, infections, falls, thrombo-embolic complications, cardiac complications, pain
Time frame: date of inclusion until end of follow-up (12 months)
Etiology of stroke, with a distinction between ischaemic stroke, hemorrhagic stroke, subarachnoid stroke or other
Time frame: date of discharge until end of follow-up (12 months)
Mortality and (severity of) disability after admission to stroke unit
Time frame: date of inclusion until end of follow-up (12 months)
Quality of care at Stroke unit of the University Hospital Ghent
Contact information is provided by the study sponsor or research team.
Dimitri Hemelsoet, MD
CONTACT
Veerle De Herdt, MD PhD
CONTACT
University Hospital, Ghent
Other
Prospective Data Collection of Patients Admitted to the Stroke Unit At University Hospital Ghent
Acronym: PRODA-STROKE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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