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NCT Number: NCT04956185

Data Collection of Patients Admitted to the Stroke Unit

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology - Ghent University Hospital

Ghent, Flanders, 9000, Belgium

Location status: Recruiting

Location contact

Veerle De Herdt, MD, PhD

CONTACT

[email protected]

+32-9-3324529

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  1. Quality of stroke care

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

    Quality of care at Stroke unit of the University Hospital Ghent

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitri Hemelsoet, MD

CONTACT

[email protected]

+3293325865

Veerle De Herdt, MD PhD

CONTACT

[email protected]

+3293326481

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: PRODA-STROKE

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Jul 9, 2021
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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