Clinical trial NCT03956485: Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).
Official title: Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracerebral Hemorrhage
Keywords: intracerebral hemorrhage
outcome
transportation
transfer
prognosis
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Fundació Ictus
name: Pla Director de la Malaltia vascular Cerebral, Departament de Salut
First posted: 2019-05-20
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Functional outcome
timeFrame: 3 months after onset
Secondary outcomes:
measure: Mortality
timeFrame: 3 months
measure: Hematoma expansion
timeFrame: 72 hours
measure: Stroke Unit admission
timeFrame: 3 months
measure: Neurological worsening
timeFrame: During admission
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Granollers
country: Spain
facility: Fundació Hospital Asil Granollers
state: Barcelona
city: Igualada
country: Spain
facility: Hospital d'Igualada
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital Moisés Broggi
state: Barcelona
city: Terrassa
country: Spain
facility: Mutua de Terrassa
state: Barcelona
city: Figueras
country: Spain
facility: Hospital de Figueras
state: Girona
city: Palamós
country: Spain
facility: Hospital de Palamós
state: Girona
city: La Seu d'Urgell
country: Spain
facility: Fundació Sant hospital de la Seu d'Urgell
state: Lleida
city: Tremp
country: Spain
facility: Hospital de Tremp
state: Lleida
city: Tortosa
country: Spain
facility: Hospital de la Cinta
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Consorci Sanitari del Garraf
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Dr Josep Trueta
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Lleida
country: Spain
facility: Hospital de la Cerdanya
city: Manresa
country: Spain
facility: Centre Hospitalari Althaia
city: Móra d'Ebre
country: Spain
facility: Hospital Comarcal Móra d'Ebre
city: Tarragona
country: Spain
facility: Hospital joan XXIII
city: Vic
country: Spain
facility: Hospital de Vic
city: Vilafranca Del Penedès
country: Spain
facility: Hospital de Vilafranca
Study officials:
References: