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Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).

Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03956485
Acronym
HIC-CAT
Enrollment
2500
Registered
2019-05-20
Start date
2019-09-30
Completion date
2021-12-31
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Keywords

intracerebral hemorrhage, outcome, transportation, transfer, prognosis

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.

Interventions

OTHERType of center

Tertiary versus non-tertiary

Sponsors

Fundació Ictus
CollaboratorUNKNOWN
Pla Director de la Malaltia vascular Cerebral, Departament de Salut
CollaboratorUNKNOWN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient with a diagnosis of spontaneous intracerebral hemorrhage who is diagnosed in any of the participant hospitals

Exclusion criteria

* Traumatic intracerebral hemorrhage * \>24 hours from onset to admission * Prior Rankin scale score \>3

Design outcomes

Primary

MeasureTime frameDescription
Functional outcome3 months after onsetRankin scale score, favourable if 0,1, 2 or 3

Secondary

MeasureTime frameDescription
Mortality3 monthsmortality within the first 3 months after onset
Hematoma expansion72 hoursincrease in hematoma volume (\>33% and/or 6 ml) from baseline CT to follow-up CT
Stroke Unit admission3 monthsPercentage of patients admitted to a stroke unit
Neurological worseningDuring admissionincrease in 4 or more points in the NIHSS score and/or decrease \>1 point in the Glasgow coma scale score

Countries

Spain

Contacts

Primary ContactJoan Martí-Fàbregas, MD,PhD
jmarti@santpau.cat+34935565986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026