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Clinical Trials/NCT04956185
NCT04956185
Recruiting
N/A

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

University Hospital, Ghent1 site in 1 country5,000 target enrollmentApril 29, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University Hospital, Ghent
Enrollment
5000
Locations
1
Primary Endpoint
Characteristics of study population
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 29, 2021
End Date
February 1, 2031
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Characteristics of study population

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

Incidence of complications at stroke unit

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

Onset-to-door

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

Time between stroke onset and arrival at Emergency Department

Patients treated with acute stroke therapy

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

Etiology of stroke

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

Outcome after 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

Mortality and disability after admission to Stroke unit

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

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

Secondary Outcomes

  • Quality of stroke care(date of inclusion until end of follow-up (12 months))

Study Sites (1)

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