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Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT). (HIC-CAT)
| Condition or disease | Intervention/treatment |
|---|---|
| Intracerebral Hemorrhage | Other: Type of center |
Introduction. Recent studies show that there are potentially beneficial therapeutic measures for the patient with acute intracerebral hemorrhage (ICH), which should be applied urgently and that some would only be available in tertiary stroke centers (TSC). However, the transportation criteria for ICH patients are not well defined.
Objectives: Design and implementation of a registry (HIC-CAT) of patients with HIC in the healthcare network of public hospitals in Catalonia, which does not modify the current logistics but collects data related to patients and TSC, interhospital transfers and non-TSC centers. The registry will allow us to evaluate the hypothesis that: 1) Patient care in TSC decreases the probability of death or dependence in patients with spontaneous ICH compared to non-TSC; and 2) The shorter the time until admission to a TSC, the better the survival and functional outcome. This will be due to the application of diagnostic, therapeutic and structural measures at the TSC. In addition, organ donation will be more frequent in a TSC.
Methods: Observational, prospective, multicentre, population study of 2500 consecutive patients with spontaneous ICH of less than 24 hours from the onset of symptoms and Rankin scale score 0-3. We will collect times, clinical and radiological variables, vital and functional outcome at 3 months follow-up. Number of organ donations. Primary variable: Functional outcome at 3 months (Rankin 0-3). Statistics: Multivariate analysis with logistic regression, propensity matching scores.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 2500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Months |
| Official Title: | Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia |
| Estimated Study Start Date : | September 2019 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | December 2021 |
- Functional outcome [ Time Frame: 3 months after onset ]Rankin scale score, favourable if 0,1, 2 or 3
- Mortality [ Time Frame: 3 months ]mortality within the first 3 months after onset
- Hematoma expansion [ Time Frame: 72 hours ]increase in hematoma volume (>33% and/or 6 ml) from baseline CT to follow-up CT
- Stroke Unit admission [ Time Frame: 3 months ]Percentage of patients admitted to a stroke unit
- Neurological worsening [ Time Frame: During admission ]increase in 4 or more points in the NIHSS score and/or decrease >1 point in the Glasgow coma scale score
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 16, 2019 | ||||
| First Posted Date | May 20, 2019 | ||||
| Last Update Posted Date | May 20, 2019 | ||||
| Estimated Study Start Date | September 2019 | ||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Functional outcome [ Time Frame: 3 months after onset ] Rankin scale score, favourable if 0,1, 2 or 3
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT). | ||||
| Official Title | Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia | ||||
| Brief Summary | A population-based registry in Catalonia of patients with acute spontaneous Intracerebral Hemorrhage, to investigate whether type of center and time from onset to admission is associated with functional outcome and mortality. | ||||
| Detailed Description |
Introduction. Recent studies show that there are potentially beneficial therapeutic measures for the patient with acute intracerebral hemorrhage (ICH), which should be applied urgently and that some would only be available in tertiary stroke centers (TSC). However, the transportation criteria for ICH patients are not well defined. Objectives: Design and implementation of a registry (HIC-CAT) of patients with HIC in the healthcare network of public hospitals in Catalonia, which does not modify the current logistics but collects data related to patients and TSC, interhospital transfers and non-TSC centers. The registry will allow us to evaluate the hypothesis that: 1) Patient care in TSC decreases the probability of death or dependence in patients with spontaneous ICH compared to non-TSC; and 2) The shorter the time until admission to a TSC, the better the survival and functional outcome. This will be due to the application of diagnostic, therapeutic and structural measures at the TSC. In addition, organ donation will be more frequent in a TSC. Methods: Observational, prospective, multicentre, population study of 2500 consecutive patients with spontaneous ICH of less than 24 hours from the onset of symptoms and Rankin scale score 0-3. We will collect times, clinical and radiological variables, vital and functional outcome at 3 months follow-up. Number of organ donations. Primary variable: Functional outcome at 3 months (Rankin 0-3). Statistics: Multivariate analysis with logistic regression, propensity matching scores. |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 3 Months | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All patients with a diagnosis of acute spontaneous intracerebral hemorrhage in Catalonia during a period of 2 years | ||||
| Condition | Intracerebral Hemorrhage | ||||
| Intervention | Other: Type of center
Tertiary versus non-tertiary
Other Name: Time from onset to admission
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment |
2500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 2021 | ||||
| Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03956485 | ||||
| Other Study ID Numbers | IIBSP-HIC-2019-22 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||
| Study Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||
| Collaborators |
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| Investigators | Not Provided | ||||
| PRS Account | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||||
| Verification Date | May 2019 | ||||
