Data Collection of Patients Admitted to the Stroke Unit

Stroke Clinical Trial

— PRODA-STROKE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04956185
• Other study ID #: BC-09645
• Status: Recruiting
• Start date: April 29, 2021
• Est. completion date: February 1, 2031

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Veerle De Herdt, MD PhD
• Phone: +3293326481
• Email: veerle.deherdt[@]uzgent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 1, 2031
• Est. primary completion date: February 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke Sequelae
• Stroke, Acute
• Stroke, Ischemic

Locations

Country	Name	City	State
Belgium	Department of Neurology - Ghent University Hospital	Ghent	Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Onset-to-door	Time between stroke onset and arrival at Emergency Department	date of inclusiondate of inclusion until end of follow-up (12 months)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)