Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí

Intracerebral Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877405
• Other study ID #: UHA-2021-1
• Status: Completed
• 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
• 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 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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

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