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

F

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Unknown

Conditions

Intracerebral Hemorrhage

Treatments

Other: Type of center

Study type

Observational

Funder types

Other

Identifiers

NCT03956485
IIBSP-HIC-2019-22

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

26

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Central trial contact

Joan Martí-Fàbregas, MD,PhD

Data sourced from clinicaltrials.gov

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