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Completed

NCT Number: NCT04877405

Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí

This is a retrospective observational study to investigate the clinical, analytical and neuroimaging data generated during routine clinical management of intracerebral hemorrhage. The study will review the data from about 500 patients attended during the last ten years in the Neurology Department of Hospital Parc Taulí de Sabadell.

The aim is to measure the size of the lesion in neuroimage (TC and MRI), the edema, the alterations in diffusion weighted images and to correlate this data with clinical parameters and analytical measurements. With this approach investigators plan to investigate the incidence of hematoma growth, the role of perilesional edema and diffusion changes, and the relation between neuroimaging findings and clinical outcome. The study also try to establish significant correlations between clinical and analytical data, the clinical outcome and and the magnitude of changes in neuroimaging.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have been attended at the Hospital Parc Taulí for the last 10 years after presenting an intraparenchymal hemorrhage.
  • The patients have had to undergo a computed tomography at the admission and a cranial magnetic resonance during the hospitalization in the time course specified in point in the protocol
  • The patients must present in their clinical story the analytical determinations detailed in the protocol.

Exclusion criteria

  • Intracerebral hemorrhage secondary to head trauma
  • Intracerebral hemorrhage secondary to neoplasm

Treatment and study plan

No intervention

Other

This observational study is not focused on therapeutic intervention

Primary outcomes

  1. Hematoma growth

    Time frame: 2 days

    Difference of hematoma size between CT conducted at admission and MRI conducted during follow up

  2. Correlation between hematoma growth and clinical paramenters

    Time frame: 2 days

    Determine the clinical parameters related with hematoma growth

  3. Correlation between hematoma growth and analytical parameters

    Time frame: 2 days

    Determine the analytical parameters related with hematoma growth

  4. Perilesional edema

    Time frame: 2 days

    Size of edema measured in FLAIR sequences

  5. Correlation between clinical parameters and the size of edema measured in FLAIR sequences

    Time frame: 2 days

    Determine the relationship between clinical parameters and the size of edema

  6. Correlation between analytical parameters and the size of edema measured in FLAIR sequences

    Time frame: 2 days

    Determine the relationship between analytical parameters and the size of edema

  7. Alterations in DWI

    Time frame: 2 days

    Size of alterations in diffusion weighted image

  8. Correlation between clinical parameters and the size of alterations in DWI

    Time frame: 2 days

    Determine the relationship between clinical parameters and the size of alterations in DWI

  9. Correlation between analytical parameters and the size of alterations in DWI

    Time frame: 2 days

    Determine the relationship between analytical parameters and the size of alterations in DWI

  10. Correlation between hematoma growth and clinical outcome

    Time frame: 1 month

    Determine the impact of hematoma growth on clinical outcome

  11. Correlation between perilesional edema size and clinical outcome

    Time frame: 1 month

    Determine the relationship between the size of edema and clinical outcome

  12. Correlation between the size of DWI alterations and clinical outcome

    Time frame: 1 month

    Determine the relationship between the size of DWI alterations and clinical outcome

  13. Correlation between the clinical parameters and clinical outcome

    Time frame: 1 month

    Determine the relationship between the clinical parametes and clinical outcome

  14. Correlation between the analyticial parameters and clinical outcome

    Time frame: 1 month

    Determine the relationship between the analytical parametes and clinical outcome

Sponsors and collaborators

Lead sponsor

Universitat Autonoma de Barcelona

Other

Collaborators

  • Parc Taulí Hospital Universitari

Registry information

Official study title

Retrospective Study to Identify Correlations Between the Clinical Parameters, Analytics and Neuroimaging Data in Patients That Suffered of Intraparenchymal Cerebral Hemorrhage

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 7, 2021
Registry last updated
May 26, 2022

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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