Clinical trial NCT04877405: Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí
Official title: Retrospective Study to Identify Correlations Between the Clinical Parameters, Analytics and Neuroimaging Data in Patients That Suffered of Intraparenchymal Cerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Lead sponsor: Universitat Autonoma de Barcelona
Sponsor class: OTHER
Collaborators: name: Parc Taulí Hospital Universitari
First posted: 2021-05-07
Enrollment: 137
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consist in the patients attended due to spontaneous intracerebral hemorrhage in Hospital Parc Taulí de Sabadell during the last decade. Traumatic or oncologic origin of the hemorrhage constitute exclusion criteria of the study.

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.


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

Primary outcomes:
measure: Hematoma growth
timeFrame: 2 days
measure: Correlation between hematoma growth and clinical paramenters
timeFrame: 2 days
measure: Correlation between hematoma growth and analytical parameters
timeFrame: 2 days
measure: Perilesional edema
timeFrame: 2 days
measure: Correlation between clinical parameters and the size of edema measured in FLAIR sequences
timeFrame: 2 days
measure: Correlation between analytical parameters and the size of edema measured in FLAIR sequences
timeFrame: 2 days
measure: Alterations in DWI
timeFrame: 2 days
measure: Correlation between clinical parameters and the size of alterations in DWI
timeFrame: 2 days
measure: Correlation between analytical parameters and the size of alterations in DWI
timeFrame: 2 days
measure: Correlation between hematoma growth and clinical outcome
timeFrame: 1 month
measure: Correlation between perilesional edema size and clinical outcome
timeFrame: 1 month
measure: Correlation between the size of DWI alterations and clinical outcome
timeFrame: 1 month
measure: Correlation between the clinical parameters and clinical outcome
timeFrame: 1 month
measure: Correlation between the analyticial parameters and clinical outcome
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cerdanyola del Valles
country: Spain
facility: Santiago Rojas Codina MD PhD
state: Barcelona
Study officials:
References: