免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Neurological Outcomes of Primary Intracerebral Haemorrhage (HIP-REA)
Neurological Outcomes of Primary Intracerebral Haemorrhage (HIP-REA)
Study Description
Brief 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).
| Condition or disease |
|---|
| Intracranial Hemorrhage, Hypertensive |
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
| Study Type : | Observational |
| Estimated Enrollment : | 40 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes |
| Actual Study Start Date : | April 30, 2019 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | January 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult patients with a primary and spontaneous supratentorial ICH
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Catherine Portal | +33.4.76.76.67.29 | bportal@chu-grenoble.fr | |
| Contact: Camille Ducki | ArcPromoteur@chu-grenoble.fr |
Locations
| France | |
| Grenoble University Hospital | Recruiting |
| Grenoble, France, 38000 | |
| Contact: Pierluigi Banco, MD +33.4.76.76.67.29 pbanco@chu-grenoble.fr | |
| Principal Investigator: Pierluigi Banco, MD | |
| Sub-Investigator: Samuel Bersinger, MD | |
Sponsors and Collaborators
University Hospital, Grenoble
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 21, 2019 | ||||
| First Posted Date | June 24, 2019 | ||||
| Last Update Posted Date | June 24, 2019 | ||||
| Actual Study Start Date | April 30, 2019 | ||||
| Estimated Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Neurological Outcomes of Primary Intracerebral Haemorrhage | ||||
| Official Title | Neurological Outcomes of Primary Intracerebral Haemorrhage Admitted in Intensive Care Unit at the University Hospital of Grenoble Alpes | ||||
| Brief 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). | ||||
| 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 Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult patients with a primary and spontaneous supratentorial ICH | ||||
| Condition | Intracranial Hemorrhage, Hypertensive | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
40 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 2020 | ||||
| Estimated Primary Completion Date | November 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03995940 | ||||
| Other Study ID Numbers | 38RC19.029 2019-A00345-52 ( Other Identifier: ID RCB ) |
||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | University Hospital, Grenoble | ||||
| Study Sponsor | University Hospital, Grenoble | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University Hospital, Grenoble | ||||
| Verification Date | June 2019 | ||||
