Intracerebral HemorrhageNCT04877405
Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí
An observational study of Intracerebral Hemorrhage, run by Universitat Autonoma de Barcelona at 1 site in Spain.
Trial summary
This is a retrospective observational study to investigate the clinical, analytical and neuroimaging data generated during routine clinical management of intracerebral hemorrhage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 137 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Intracerebral hemorrhage secondary to head trauma
- Intracerebral hemorrhage secondary to neoplasm
Trial locations and contacts
1 site in 1 country.
Spain1 site
Santiago Rojas Codina MD PhD
Cerdanyola del Vallès, Barcelona, 08193
About this study
Official title: Retrospective Study to Identify Correlations Between the Clinical Parameters, Analytics and Neuroimaging Data in Patients That Suffered of Intraparenchymal Cerebral Hemorrhage
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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- No intervention
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This observational study is not focused on therapeutic intervention
| Study group | Role | What they receive |
|---|---|---|
| Intracerebral hemorraghe | Patients that suffered an intracerebral hemorraghe and that have been subjected to CT and MRI scans Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma growth
Difference of hematoma size between CT conducted at admission and MRI conducted during follow up
Measured: 2 days
Correlation between hematoma growth and clinical paramenters
Determine the clinical parameters related with hematoma growth
Measured: 2 days
Correlation between hematoma growth and analytical parameters
Determine the analytical parameters related with hematoma growth
Measured: 2 days
Perilesional edema
Size of edema measured in FLAIR sequences
Measured: 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
Measured: 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
Measured: 2 days
Alterations in DWI
Size of alterations in diffusion weighted image
Measured: 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
Measured: 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
Measured: 2 days
Correlation between hematoma growth and clinical outcome
Determine the impact of hematoma growth on clinical outcome
Measured: 1 month
Correlation between perilesional edema size and clinical outcome
Determine the relationship between the size of edema and clinical outcome
Measured: 1 month
Correlation between the size of DWI alterations and clinical outcome
Determine the relationship between the size of DWI alterations and clinical outcome
Measured: 1 month
Correlation between the clinical parameters and clinical outcome
Determine the relationship between the clinical parametes and clinical outcome
Measured: 1 month
Correlation between the analyticial parameters and clinical outcome
Determine the relationship between the analytical parametes and clinical outcome
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start10 May 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Autonoma de Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Taulí Hospital Universitari
- Responsible party
- Principal investigator, Santiago Rojas Codina MD PhD, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877405
- Sponsor's protocol ID
- UHA-2021-1
- Status last verified
- May 2022
- First submitted
- 29 Apr 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared with other researchers under request
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Identify Correlations Between the Clinical Parameters, Analytics and Neuroimaging Data in Patients That Suffered of Intraparenchymal Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT04877405
- Acronym / sponsor ID
- UHA-2021-1
- Conditions
- Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Universitat Autonoma de BarcelonaUniversity, hospital or other
- Collaborators
- Parc Taulí Hospital Universitari
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracerebral hemorraghe | – | Other: No interventionPatients that suffered an intracerebral hemorraghe and that have been subjected to CT and MRI scans |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Intracerebral hemorrhage secondary to head trauma
- Intracerebral hemorrhage secondary to neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis observational study is not focused on therapeutic intervention | Other | Intracerebral hemorraghe |
Primary outcome
Hematoma growth
Time frame: 2 days
Difference of hematoma size between CT conducted at admission and MRI conducted during follow up
Correlation between hematoma growth and clinical paramenters
Time frame: 2 days
Determine the clinical parameters related with hematoma growth
Correlation between hematoma growth and analytical parameters
Time frame: 2 days
Determine the analytical parameters related with hematoma growth
Perilesional edema
Time frame: 2 days
Size of edema measured in FLAIR sequences
Correlation between clinical parameters and the size of edema measured in FLAIR sequences
Time frame: 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
Time frame: 2 days
Determine the relationship between analytical parameters and the size of edema
Alterations in DWI
Time frame: 2 days
Size of alterations in diffusion weighted image
Correlation between clinical parameters and the size of alterations in DWI
Time frame: 2 days
Determine the relationship between clinical parameters and the size of alterations in DWI
Correlation between analytical parameters and the size of alterations in DWI
Time frame: 2 days
Determine the relationship between analytical parameters and the size of alterations in DWI
Correlation between hematoma growth and clinical outcome
Time frame: 1 month
Determine the impact of hematoma growth on clinical outcome
Correlation between perilesional edema size and clinical outcome
Time frame: 1 month
Determine the relationship between the size of edema and clinical outcome
Correlation between the size of DWI alterations and clinical outcome
Time frame: 1 month
Determine the relationship between the size of DWI alterations and clinical outcome
Correlation between the clinical parameters and clinical outcome
Time frame: 1 month
Determine the relationship between the clinical parametes and clinical outcome
Correlation between the analyticial parameters and clinical outcome
Time frame: 1 month
Determine the relationship between the analytical parametes and clinical outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Undecided. IPD may be shared with other researchers under request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by Universitat Autonoma de Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma growth (time frame: 2 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.