Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí

Completed

• Conditions: Intracerebral Hemorrhage
• Interventions: Other: No intervention

• Registration Number: NCT04877405
• Lead Sponsor: Universitat Autonoma de Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-07
• Study Start: 2021-05-10
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intracerebral hemorraghe	No intervention	Patients that suffered an intracerebral hemorraghe and that have been subjected to CT and MRI scans

Primary Outcome Measures

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

Trial Locations

Locations (1)

Santiago Rojas Codina MD PhD; 🇪🇸 Cerdanyola del Valles, Barcelona, Spain