NCT03956485

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
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
OTHER	Type of center	Tertiary versus non-tertiary

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2019-05-20
• Last updated: 2019-05-20

Locations

26 sites across 1 country: Spain