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

Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia

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.

Study Overview

• Status: Unknown
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Other: Type of center

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.

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Joan Martí-Fàbregas, MD,PhD; Phone Number: +34935565986; Email: jmarti@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Clínic
  • Barcelona, Spain
    • Consorci Sanitari del Garraf
  • Girona, Spain
    • Hospital Dr Josep Trueta
  • Lleida, Spain
    • Hospital Arnau de Vilanova
  • Lleida, Spain
    • Hospital de la Cerdanya
  • Manresa, Spain
    • Centre Hospitalari Althaia
  • Móra d'Ebre, Spain
    • Hospital Comarcal Móra d'Ebre
  • Tarragona, Spain
    • Hospital Joan XXIII
  • Vic, Spain
    • Hospital de Vic
  • Vilafranca Del Penedès, Spain
    • Hospital de Vilafranca
  • Barcelona
    • Badalona, Barcelona, Spain
      • Hospital Germans Trias i Pujol
    • Granollers, Barcelona, Spain
      • Fundació Hospital Asil Granollers
    • Igualada, Barcelona, Spain
      • Hospital d'Igualada
    • L'Hospitalet De Llobregat, Barcelona, Spain
      • Hospital de Bellvitge
    • Mataró, Barcelona, Spain
      • Hospital de Mataró
    • Sabadell, Barcelona, Spain
      • Hospital Parc Taulí
    • Sant Joan Despí, Barcelona, Spain
      • Hospital Moisés Broggi
    • Terrassa, Barcelona, Spain
      • Mutua de Terrassa
  • Girona
    • Figueras, Girona, Spain
      • Hospital de Figueras
    • Palamós, Girona, Spain
      • Hospital de Palamós
  • Lleida
    • La Seu d'Urgell, Lleida, Spain
      • Fundació Sant hospital de la Seu d'Urgell
    • Tremp, Lleida, Spain
      • Hospital de Tremp
  • Tarragona
    • Tortosa, Tarragona, Spain
      • Hospital de la Cinta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a diagnosis of acute spontaneous intracerebral hemorrhage in Catalonia during a period of 2 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	Rankin scale score, favourable if 0,1, 2 or 3	3 months after onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	mortality within the first 3 months after onset	3 months
Hematoma expansion	increase in hematoma volume (>33% and/or 6 ml) from baseline CT to follow-up CT	72 hours
Stroke Unit admission	Percentage of patients admitted to a stroke unit	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	During admission

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Fundació Ictus; Pla Director de la Malaltia vascular Cerebral, Departament de Salut

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: prognosis; outcome; intracerebral hemorrhage; transportation; transfer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: IIBSP-HIC-2019-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No