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

Overview

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 Title of Study: “Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2021

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

  • Other: Type of center
    • Tertiary versus non-tertiary

Clinical Trial Outcome Measures

Primary Measures

  • Functional outcome
    • Time Frame: 3 months after onset
    • Rankin scale score, favourable if 0,1, 2 or 3

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau
  • Collaborator
    • Fundació Ictus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Joan Martí-Fàbregas, MD,PhD, +34935565986, jmarti@santpau.cat

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.