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

Intracerebral Hemorrhage Clinical Trial

— HIC-CAT  

Official title:

Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03956485
• Other study ID #: IIBSP-HIC-2019-22
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: December 2021

Study information

• Verified date: May 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Joan Martí-Fàbregas, MD,PhD
• Phone: +34935565986
• Email: jmarti[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Other:
• Type of center
Tertiary versus non-tertiary

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Fundació Ictus, Pla Director de la Malaltia vascular Cerebral, Departament de Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	Rankin scale score, favourable if 0,1, 2 or 3	3 months after onset
Secondary	Mortality	mortality within the first 3 months after onset	3 months
Secondary	Hematoma expansion	increase in hematoma volume (>33% and/or 6 ml) from baseline CT to follow-up CT	72 hours
Secondary	Stroke Unit admission	Percentage of patients admitted to a stroke unit	3 months
Secondary	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