NCT03956485

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

26 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 16, 2019

Last Update Submit

May 16, 2019

Conditions

Keywords

intracerebral hemorrhageoutcometransportationtransferprognosis

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

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

    3 months after onset

Secondary Outcomes (4)

  • Mortality

    3 months

  • Hematoma expansion

    72 hours

  • Stroke Unit admission

    3 months

  • Neurological worsening

    During admission

Interventions

Tertiary versus non-tertiary

Also known as: Time from onset to admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Fundació Hospital Asil Granollers

Granollers, Barcelona, Spain

Location

Hospital d'Igualada

Igualada, Barcelona, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital de Mataró

Mataró, Barcelona, Spain

Location

Hospital Parc Taulí

Sabadell, Barcelona, Spain

Location

Hospital Moisés Broggi

Sant Joan Despí, Barcelona, Spain

Location

Mutua de Terrassa

Terrassa, Barcelona, Spain

Location

Hospital de Figueras

Figueras, Girona, Spain

Location

Hospital de Palamós

Palamós, Girona, Spain

Location

Fundació Sant hospital de la Seu d'Urgell

La Seu d'Urgell, Lleida, Spain

Location

Hospital de Tremp

Tremp, Lleida, Spain

Location

Hospital de la Cinta

Tortosa, Tarragona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Consorci Sanitari del Garraf

Barcelona, Spain

Location

Hospital Clínic

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Dr Josep Trueta

Girona, Spain

Location

Hospital Arnau de Vilanova

Lleida, Spain

Location

Hospital de la Cerdanya

Lleida, Spain

Location

Centre Hospitalari Althaia

Manresa, Spain

Location

Hospital Comarcal Móra d'Ebre

Móra d'Ebre, Spain

Location

Hospital joan XXIII

Tarragona, Spain

Location

Hospital de Vic

Vic, Spain

Location

Hospital de Vilafranca

Vilafranca del Penedès, Spain

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Joan Martí-Fàbregas, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 20, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations