NCT04877405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

April 29, 2021

Last Update Submit

May 19, 2022

Conditions

Outcome Measures

Primary Outcomes (14)

  • Hematoma growth

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

    2 days

  • Correlation between hematoma growth and clinical paramenters

    Determine the clinical parameters related with hematoma growth

    2 days

  • Correlation between hematoma growth and analytical parameters

    Determine the analytical parameters related with hematoma growth

    2 days

  • Perilesional edema

    Size of edema measured in FLAIR sequences

    2 days

  • 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

  • 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

  • Alterations in DWI

    Size of alterations in diffusion weighted image

    2 days

  • 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

  • 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

  • Correlation between hematoma growth and clinical outcome

    Determine the impact of hematoma growth on clinical outcome

    1 month

  • Correlation between perilesional edema size and clinical outcome

    Determine the relationship between the size of edema and clinical outcome

    1 month

  • Correlation between the size of DWI alterations and clinical outcome

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

    1 month

  • Correlation between the clinical parameters and clinical outcome

    Determine the relationship between the clinical parametes and clinical outcome

    1 month

  • Correlation between the analyticial parameters and clinical outcome

    Determine the relationship between the analytical parametes and clinical outcome

    1 month

Study Arms (1)

Intracerebral hemorraghe

Patients that suffered an intracerebral hemorraghe and that have been subjected to CT and MRI scans

Other: No intervention

Interventions

This observational study is not focused on therapeutic intervention

Intracerebral hemorraghe

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Intracerebral hemorrhage secondary to head trauma
  • Intracerebral hemorrhage secondary to neoplasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santiago Rojas Codina MD PhD

Cerdanyola del Vallès, Barcelona, 08193, Spain

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 7, 2021

Study Start

May 10, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations