An observational study in Intracerebral Hemorrhage, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 26 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-20.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 275 across 180 observational studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with a diagnosis of acute spontaneous intracerebral hemorrhage in Catalonia during a period of 2 years
Exclusion Criteria:
Tertiary versus non-tertiary
Also known as: Time from onset to admission
Functional outcome
Rankin scale score, favourable if 0,1, 2 or 3
Time frame: 3 months after onset
Mortality
mortality within the first 3 months after onset
Time frame: 3 months
Hematoma expansion
increase in hematoma volume (\>33% and/or 6 ml) from baseline CT to follow-up CT
Time frame: 72 hours
Stroke Unit admission
Percentage of patients admitted to a stroke unit
Time frame: 3 months
Neurological worsening
increase in 4 or more points in the NIHSS score and/or decrease \>1 point in the Glasgow coma scale score
Time frame: During admission
Plan to share: No
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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau