Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí

• Sponsor: Universitat Autonoma de Barcelona (Other)
• Overall Status: Completed
• CT.gov ID: NCT04877405
• Collaborator: Hospital Parc Taulí, Sabadell (Other)
• Enrollment: 137
• Location: 1
• Actual Duration (Months): 10.7
• Patients Per Site Per Month: 12.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage	Other: No intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 137 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Retrospective Study to Identify Correlations Between the Clinical Parameters, Analytics and Neuroimaging Data in Patients That Suffered of Intraparenchymal Cerebral Hemorrhage
• Actual Study Start Date: May 10, 2021
• Actual Primary Completion Date: Mar 31, 2022
• Actual Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Intracerebral hemorraghe Patients that suffered an intracerebral hemorraghe and that have been subjected to CT and MRI scans	Other: No intervention; This observational study is not focused on therapeutic intervention

Outcome Measures

Primary Outcome Measures

1. Hematoma growth [2 days]

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

2. Correlation between hematoma growth and clinical paramenters [2 days]

   Determine the clinical parameters related with hematoma growth

3. Correlation between hematoma growth and analytical parameters [2 days]

   Determine the analytical parameters related with hematoma growth

4. Perilesional edema [2 days]

   Size of edema measured in FLAIR sequences

5. 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

6. 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

7. Alterations in DWI [2 days]

   Size of alterations in diffusion weighted image

8. 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

9. 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

10. Correlation between hematoma growth and clinical outcome [1 month]

    Determine the impact of hematoma growth on clinical outcome

11. Correlation between perilesional edema size and clinical outcome [1 month]

    Determine the relationship between the size of edema and clinical outcome

12. Correlation between the size of DWI alterations and clinical outcome [1 month]

    Determine the relationship between the size of DWI alterations and clinical outcome

13. Correlation between the clinical parameters and clinical outcome [1 month]

    Determine the relationship between the clinical parametes and clinical outcome

14. Correlation between the analyticial parameters and clinical outcome [1 month]

    Determine the relationship between the analytical parametes and clinical outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santiago Rojas Codina MD PhD	Cerdanyola del Valles	Barcelona	Spain	08193

Sponsors and Collaborators

• Universitat Autonoma de Barcelona
• Hospital Parc Taulí, Sabadell

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santiago Rojas Codina MD PhD, Principal investigator, Universitat Autonoma de Barcelona
• ClinicalTrials.gov Identifier: NCT04877405
• Other Study ID Numbers: UHA-2021-1
• First Posted: May 7, 2021
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Hemorrhage; Hemorrhage

Study Results

No Results Posted as of May 26, 2022