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

NCT ID: NCT03956485

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2021-12-31

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Type of center

Tertiary versus non-tertiary

Intervention Type: OTHER

Other Intervention Names

Time from onset to admission

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Ictus

UNKNOWN

Sponsor Role: collaborator

Pla Director de la Malaltia vascular Cerebral, Departament de Salut

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Fundació Hospital Asil Granollers

Granollers, Barcelona, Spain

Hospital d'Igualada

Igualada, Barcelona, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital de Mataró

Mataró, Barcelona, Spain

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Hospital Moisés Broggi

Sant Joan Despí, Barcelona, Spain

Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital de Figueras

Figueras, Girona, Spain

Hospital de Palamós

Palamós, Girona, Spain

Fundació Sant hospital de la Seu d'Urgell

La Seu d'Urgell, Lleida, Spain

Hospital de Tremp

Tremp, Lleida, Spain

Hospital de la Cinta

Tortosa, Tarragona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Consorci Sanitari del Garraf

Barcelona, , Spain

Hospital Clínic

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Dr Josep Trueta

Girona, , Spain

Hospital Arnau de Vilanova

Lleida, , Spain

Hospital de la Cerdanya

Lleida, , Spain

Centre Hospitalari Althaia

Manresa, , Spain

Hospital Comarcal Móra d'Ebre

Móra d'Ebre, , Spain

Hospital joan XXIII

Tarragona, , Spain

Hospital de Vic

Vic, , Spain

Hospital de Vilafranca

Vilafranca del Penedès, , Spain

Countries

Spain

Central Contacts

Joan Martí-Fàbregas, MD,PhD

Role: CONTACT

jmarti@santpau.cat

+34935565986

References

Lambea-Gil A, Marti-Fabregas J, Cardona P, Rodriguez-Luna D, Millan M, Amaro S, Prats-Sanchez L, Silva Y, Sero L, Rodriguez-Campello A, Canovas D, Martinez-Domeno A, Guasch-Jimenez M, Ezcurra-Diaz G, Carcel-Marquez J, Fernandez-Cadenas I, Perez De La Ossa N, Abilleira S, Salvat-Plana M, Fagundez O, Camps-Renom P, Ramos-Pachon A; as the HIC-CAT investigators. Effect of Onset-to-Admission Time and Care Bundle Achievement on Functional Outcomes in Patients With ICH: A Population-Based Study. Neurology. 2025 Oct 21;105(8):e214176. doi: 10.1212/WNL.0000000000214176. Epub 2025 Sep 30.

Reference Type: DERIVED

PMID: 41026995 (View on PubMed)

Marti-Fabregas J, Ramos-Pachon A, Prats-Sanchez L, Nunez-Guillen A, Rodriguez BL, Rodriguez-Luna D, Amaro S, Silva Y, Rodriguez-Campello A, Puig I, Gomez-Choco M, Vazquez-Justes D, Guanyabens N, Cocho D, Canovas D, Steinhauer EG, Llull L, Guasch-Jimenez M, Martinez-Domeno A, Marin R, Lambea-Gil A, Diaz GE, Paipa-Merchan A, Quesada H, Casadevall MP, Wenger D, Pancorbo O, Sero L, Perez J, Costa X, Zaragoza J, Rodriguez-Villatoro N, Catena E, Calvo NM, Krupinski J, De La Ossa NP, Abilleira S, Salvat-Planas M, Fagundez O, Camps-Renom P; for HIC-CAT. Influence of Hospital Type on Outcomes of Patients With Acute Spontaneous Intracerebral Hemorrhage: A Population-Based Study. Neurology. 2024 Jul 23;103(2):e209539. doi: 10.1212/WNL.0000000000209539. Epub 2024 Jun 14.

Reference Type: DERIVED

PMID: 38875516 (View on PubMed)

Other Identifiers

IIBSP-HIC-2019-22

Identifier Type: -

Identifier Source: org_study_id