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Clinical Trials/NCT04877405
NCT04877405
Completed
N/A

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

Universitat Autonoma de Barcelona1 site in 1 country137 target enrollmentMay 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intracerebral Hemorrhage
Sponsor
Universitat Autonoma de Barcelona
Enrollment
137
Locations
1
Primary Endpoint
Hematoma growth
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 10, 2021
End Date
March 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Universitat Autonoma de Barcelona
Responsible Party
Principal Investigator
Principal Investigator

Santiago Rojas Codina MD PhD

Principal investigator

Universitat Autonoma de Barcelona

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hematoma growth

Time Frame: 2 days

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

Correlation between hematoma growth and analytical parameters

Time Frame: 2 days

Determine the analytical parameters related with hematoma growth

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

Alterations in DWI

Time Frame: 2 days

Size of alterations in diffusion weighted image

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

Correlation between hematoma growth and clinical paramenters

Time Frame: 2 days

Determine the clinical parameters related with hematoma growth

Correlation between perilesional edema size and clinical outcome

Time Frame: 1 month

Determine the relationship between the size of edema and clinical outcome

Perilesional edema

Time Frame: 2 days

Size of edema measured in FLAIR sequences

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

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

Correlation between hematoma growth and clinical outcome

Time Frame: 1 month

Determine the impact of hematoma growth on clinical outcome

Correlation between the clinical parameters and clinical outcome

Time Frame: 1 month

Determine the relationship between the clinical parametes and clinical outcome

Correlation between the analyticial parameters and clinical outcome

Time Frame: 1 month

Determine the relationship between the analytical parametes and clinical outcome

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

Study Sites (1)

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