Intracranial Hemorrhage, HypertensiveHIP-REANCT03995940
Neurological Outcomes of Primary Intracerebral Haemorrhage
An observational study of Intracranial Hemorrhage, Hypertensive, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective of this study is to determine the one-year neurological outcome of patients admitted to an intensive care unit (ICU) for a primary and spontaneous supratentorial intracerebral hemorrhages (ICH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhage, Hypertensive
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2019to Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a primary and spontaneous supratentorial ICH
Who may be able to join
- Admission in one of the four University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for primary and spontaneous supratentorial ICH.
- Not opposed to participate in a research protocol (asked by phone call)
Who cannot join
- Pediatric patient
- Infra-tentorials ICH
- No spontaneous ICH (after head trauma)
- Secondary ICH (anevrisum, arteriovenous malformation, tumor, hemorrhagic transformation, vascularitis)
- Persons referred to in Articles L1121-5 to L1121-8 of the french public health code
Trial locations and contacts
1 site in 1 country.
Camille Ducki contact
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, 38000
Pierluigi Banco, MD, +33.4.76.76.67.29, pbanco@chu-grenoble.fr
Pierluigi Banco, MD
About this study
Official title: Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes
The main objective of this study is to determine the one-year neurological outcome of patients admitted to an intensive care unit (ICU) for a primary and spontaneous supratentorial intracerebral hemorrhages (ICH).
Read the detailed description
ICH represent a diagnostic and therapeutic emergency. ICH account for 20% of strokes with a one-year mortality of more than 45% and an uncertain neurological outcome.
For ICH patients, the main initial challenge is to determine the long term neurological outcomes and adapt the therapeutic strategy.
The majority of primary and spontaneous ICH studies involve patients in stroke units.
The study is an observational type 3 research with all the patients admitted in all the University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for a primary and spontaneous supratentorial ICH
- Conditions
- Intracranial Hemorrhage, Hypertensive
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcomes
Collection of the Modified Ranking Scale (mRS) at one year by patients phone call or with the medicale file.
Measured: One year after the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start30 Apr 2019
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Hemorrhage, HypertensiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995940
- Sponsor's protocol ID
- 38RC19.029
- Other IDs
- 2019-A00345-52
- Acronym
- HIP-REA
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes
- ClinicalTrials.gov ID
- NCT03995940
- Acronym / sponsor ID
- HIP-REA / 38RC19.029
- Conditions
- Intracranial Hemorrhage, Hypertensive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Jun 2019 (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.
The main objective of this study is to determine the one-year neurological outcome of patients admitted to an intensive care unit (ICU) for a primary and spontaneous supratentorial intracerebral hemorrhages (ICH).
Detailed description
ICH represent a diagnostic and therapeutic emergency. ICH account for 20% of strokes with a one-year mortality of more than 45% and an uncertain neurological outcome.
For ICH patients, the main initial challenge is to determine the long term neurological outcomes and adapt the therapeutic strategy.
The majority of primary and spontaneous ICH studies involve patients in stroke units.
The study is an observational type 3 research with all the patients admitted in all the University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for a primary and spontaneous supratentorial ICH
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a primary and spontaneous supratentorial ICH
Key inclusion criteria (2 listed)
- Admission in one of the four University Hospital of Grenoble Alpes ICUs between July 2012 and July 2017 for primary and spontaneous supratentorial ICH.
- Not opposed to participate in a research protocol (asked by phone call)
Key exclusion criteria (5 listed)
- Pediatric patient
- Infra-tentorials ICH
- No spontaneous ICH (after head trauma)
- Secondary ICH (anevrisum, arteriovenous malformation, tumor, hemorrhagic transformation, vascularitis)
- Persons referred to in Articles L1121-5 to L1121-8 of the french public health code
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological outcomes
Time frame: One year after the stroke
Collection of the Modified Ranking Scale (mRS) at one year by patients phone call or with the medicale file.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
Camille Ducki contact
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 Intracranial Hemorrhage, Hypertensive, run by University Hospital, Grenoble at 1 site in France.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Portal (+33.4.76.76.67.29, bportal@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcomes (time frame: One year after the stroke). 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 24 Jun 2019.