Multicentre Registry of Patients With Spontaneous Acute Intracerebral

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03956485
Study type	Observational [Patient Registry]
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
Status	Not yet recruiting
Phase
Start date	September 2019
Completion date	December 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms