Data Collection of Patients Admitted to the Stroke Unit (PRODA-STROKE)

Prospective Data Collection of Patients Admitted to the Stroke Unit at University Hospital Ghent

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute; Stroke Sequelae; Stroke Hemorrhagic

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Veerle De Herdt, MD PhD; Phone Number: +3293326481; Email: veerle.deherdt@uzgent.be
• Study Contact Backup: Name: Dimitri Hemelsoet, MD; Phone Number: +3293325865; Email: dimitri.hemelsoet@ugent.be

Study Locations

• Belgium
  • Flanders
    • Ghent, Flanders, Belgium, 9000
      • Recruiting
      • Department of Neurology - Ghent University Hospital
      • Contact: Veerle De Herdt, MD, PhD; Phone Number: +32-9-3324529; Email: Veerle.DeHerdt@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of stroke care	Quality of care at Stroke unit of the University Hospital Ghent	date of inclusion until end of follow-up (12 months)

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: BC-09645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No