Data Collection of Patients Admitted to the Stroke Unit

NCT04956185 | Recruiting DMC

• 1 other identifier: BC-09645
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Stroke, Acute; Stroke, Ischemic; Stroke Hemorrhagic; Stroke Sequelae

Outcome Measures

Primary Outcomes (7)

• Characteristics of study population

  Information about patients included in the stroke database: age, gender, medical/family history

  date of inclusion until end of follow-up (12 months)

• Onset-to-door

  Time between stroke onset and arrival at Emergency Department

  date of inclusiondate of inclusion until end of follow-up (12 months)

• Patients treated with acute stroke therapy

  Patients treated with acute stroke therapy (i.e. thrombolysis and/or thrombectomy), start time of acute therapy

  date of inclusion until end of follow-up (12 months)

• Outcome after acute therapy

  Outcome after acute therapy, assessed by NIHSS and mRS score, possible complications and imaging

  date of inclusion until end of follow-up (12 months)

• Incidence of complications at stroke unit

  Incidence of neurological complications, epilepsy, infections, falls, thrombo-embolic complications, cardiac complications, pain

  date of inclusion until end of follow-up (12 months)

• Etiology of stroke

  Etiology of stroke, with a distinction between ischaemic stroke, hemorrhagic stroke, subarachnoid stroke or other

  date of inclusion until end of follow-up (12 months)

• Mortality and disability after admission to Stroke unit

  Mortality and (severity of) disability after admission to stroke unit

  date of discharge until end of follow-up (12 months)

Secondary Outcomes (1)

• Quality of stroke care

  date of inclusion until end of follow-up (12 months)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the Stroke unit (or to any other hospital ward) with a cerebrovascular disease and who have given their informed consent for data collection (or whose legal representative has given informed consent for data collection).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Department of Neurology - Ghent University Hospital

Ghent, Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Veerle De Herdt, MD PhD

CONTACT

+3293326481; veerle.deherdt@uzgent.be

Dimitri Hemelsoet, MD

CONTACT

+3293325865; dimitri.hemelsoet@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: July 9, 2021
• Study Start: April 29, 2021
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)