Data Collection of Patients Admitted to the Stroke Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke, Stroke, Acute, Stroke, Ischemic, Stroke Hemorrhagic. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Data Collection of Patients Admitted to the Stroke Unit At University Hospital Ghent
Overview
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.
Detailed description
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:
* Demographical information: gender, year of birth * Relevant medical history: vascular risk profile, neurological history, psychiatric history, pre-stroke modified Rankin Score (mRS), home medication * Neurological evaluation upon admission to Emergency Department: vital parameters, clinical neurological evaluation, results imaging * Data concerning acute stroke therapy: intravenous thrombolysis, intra-arterial thrombectomy, medication started at the Emergency Department, neurosurgical procedures if performed, (neurological) evaluation after treatment * Course of hospitalisation: complications (neurological deterioration, epilepsy, infections, falls, speech or swallow disturbances, thrombo-embolic complications, pain, cardiac complications), start of medication, treatment (such as physiotherapy, occupational therapy), date of discharge, mRS and NIHSS score at discharge, care after discharge * Results stroke-investigations: imaging of brain and neck vessels, telemetry, Holter monitoring, transthoracic and/or transesophageal ultrasound, blood workup, electro-encephalographic investigations, genetic workup, etiology of stroke * Therapy at discharge: medication, revalidation * mRS score during follow-up at policlinic neurology
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.
Primary outcome measures
- Characteristics of study population [Time frame: date of inclusion until end of follow-up (12 months)]
- Onset-to-door [Time frame: date of inclusiondate of inclusion until end of follow-up (12 months)]
- Patients treated with acute stroke therapy [Time frame: date of inclusion until end of follow-up (12 months)]
- Outcome after acute therapy [Time frame: date of inclusion until end of follow-up (12 months)]
- Incidence of complications at stroke unit [Time frame: date of inclusion until end of follow-up (12 months)]
- Etiology of stroke [Time frame: date of inclusion until end of follow-up (12 months)]
- Mortality and disability after admission to Stroke unit [Time frame: date of discharge until end of follow-up (12 months)]
Secondary outcome measures (1)
- Quality of stroke care [Time frame: date of inclusion until end of follow-up (12 months)]
Eligibility criteria
Inclusion criteria
- Patients admitted to the Stroke unit with a cerebrovascular disease
- Patients admitted to the regular neurological ward or any other department in the University Hospital Ghent with a cerebrovascular disease who are actively followed by the department of Neurology during hospitalisation
- Patients who have given their explicit informed consent for data collection
Exclusion criteria
- Patients who have not given informed consent for data collection
- Patients who are not able to give informed consent and whose legal representative has not given informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- Department of Neurology - Ghent University Hospital — Ghent
Identifiers
NCT: NCT04956185 · BC-09645