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Intracerebral HemorrhageHIC-CATNCT03956485

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

An observational study of Intracerebral Hemorrhage, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 26 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Type of center
How many people
2,500 participants
Where
26 sitesSpain
Study dates
Sep 2019to Dec 2021
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Patient with a diagnosis of spontaneous intracerebral hemorrhage who is diagnosed in any of the participant hospitals

Who cannot join

  • Traumatic intracerebral hemorrhage
  • >24 hours from onset to admission
  • Prior Rankin scale score >3

Trial locations and contacts

26 sites in 1 country.

Joan Martí-Fàbregas, MD,PhD contact

+34935565986

jmarti@santpau.cat

26 sites in 1 country

Spain26 sites

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Consorci Sanitari del Garraf

    Barcelona

  • Hospital Clínic

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital de Figueras

    Figueras, Girona

  • Hospital Dr Josep Trueta

    Girona

  • Fundació Hospital Asil Granollers

    Granollers, Barcelona

  • Hospital d'Igualada

    Igualada, Barcelona

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

  • Fundació Sant hospital de la Seu d'Urgell

    La Seu d'Urgell, Lleida

  • Hospital Arnau de Vilanova

    Lleida

  • Hospital de la Cerdanya

    Lleida

  • Centre Hospitalari Althaia

    Manresa

  • Hospital de Mataró

    Mataró, Barcelona

  • Hospital Comarcal Móra d'Ebre

    Móra d'Ebre

  • Hospital de Palamós

    Palamós, Girona

  • Hospital Parc Taulí

    Sabadell, Barcelona

  • Hospital Moisés Broggi

    Sant Joan Despí, Barcelona

  • Hospital joan XXIII

    Tarragona

  • Mutua de Terrassa

    Terrassa, Barcelona

  • Hospital de la Cinta

    Tortosa, Tarragona

  • Hospital de Tremp

    Tremp, Lleida

  • Hospital de Vic

    Vic

  • Hospital de Vilafranca

    Vilafranca del Penedès

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Type of center
Keywords
intracerebral hemorrhage, outcome, transportation, transfer, prognosis
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Type of centerOther

    Also called Time from onset to admission

    Tertiary versus non-tertiary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional outcome

    Rankin scale score, favourable if 0,1, 2 or 3

    Measured: 3 months after onset

Secondary outcomes (4)

  1. Mortality

    mortality within the first 3 months after onset

    Measured: 3 months

  2. Hematoma expansion

    increase in hematoma volume (>33% and/or 6 ml) from baseline CT to follow-up CT

    Measured: 72 hours

  3. Stroke Unit admission

    Percentage of patients admitted to a stroke unit

    Measured: 3 months

  4. Neurological worsening

    increase in 4 or more points in the NIHSS score and/or decrease >1 point in the Glasgow coma scale score

    Measured: During admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study startSep 2019 (estimated)
  3. Primary completionSep 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03956485
Sponsor's protocol ID
IIBSP-HIC-2019-22
Acronym
HIC-CAT
Status last verified
May 2019
First submitted
16 May 2019
Last updated
20 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41026995

  • 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.

    PubMed 38875516

Questions about this trial

What is this clinical trial studying?

An observational study of Intracerebral Hemorrhage, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 26 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joan Martí-Fàbregas, MD,PhD (+34935565986, jmarti@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional outcome (time frame: 3 months after onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03956485, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.

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