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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04877405
Other study ID # UHA-2021-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 10, 2021
Est. completion date March 31, 2022

Study information

Verified date May 2022
Source Universitat Autonoma de Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who have been attended at the Hospital Parc TaulĂ­ 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This observational study is not focused on therapeutic intervention

Locations

Country Name City State
Spain Santiago Rojas Codina MD PhD Cerdanyola del Valles Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Universitat Autonoma de Barcelona Hospital Parc Taulí, Sabadell

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hematoma growth Difference of hematoma size between CT conducted at admission and MRI conducted during follow up 2 days
Primary Correlation between hematoma growth and clinical paramenters Determine the clinical parameters related with hematoma growth 2 days
Primary Correlation between hematoma growth and analytical parameters Determine the analytical parameters related with hematoma growth 2 days
Primary Perilesional edema Size of edema measured in FLAIR sequences 2 days
Primary Correlation between clinical parameters and the size of edema measured in FLAIR sequences Determine the relationship between clinical parameters and the size of edema 2 days
Primary Correlation between analytical parameters and the size of edema measured in FLAIR sequences Determine the relationship between analytical parameters and the size of edema 2 days
Primary Alterations in DWI Size of alterations in diffusion weighted image 2 days
Primary Correlation between clinical parameters and the size of alterations in DWI Determine the relationship between clinical parameters and the size of alterations in DWI 2 days
Primary Correlation between analytical parameters and the size of alterations in DWI Determine the relationship between analytical parameters and the size of alterations in DWI 2 days
Primary Correlation between hematoma growth and clinical outcome Determine the impact of hematoma growth on clinical outcome 1 month
Primary Correlation between perilesional edema size and clinical outcome Determine the relationship between the size of edema and clinical outcome 1 month
Primary Correlation between the size of DWI alterations and clinical outcome Determine the relationship between the size of DWI alterations and clinical outcome 1 month
Primary Correlation between the clinical parameters and clinical outcome Determine the relationship between the clinical parametes and clinical outcome 1 month
Primary Correlation between the analyticial parameters and clinical outcome Determine the relationship between the analytical parametes and clinical outcome 1 month
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