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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03956485
Other study ID # IIBSP-HIC-2019-22
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Type of center
Tertiary versus non-tertiary

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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
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