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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01990014
Other study ID # BRD/10/08-I
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2011
Est. completion date July 2013

Study information

Verified date September 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke who received a decompressive craniotomy in the acute phase. Patients who have given their consent to be evaluated at least two years after their stroke and their operation in a single visit by clinical examination and procurement of standardized scales. Will be measured the quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The existence of predictive parameters of long-term evolution will be searched in determining the existence of a correlation between demographic data and baseline characteristics of the stroke on and the evolution of the quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date July 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age> = 18 years - Having presented an ischemic stroke involving the sylvian area - Having received decompressive craniectomy in acute ischemic stroke - Time between stroke and the inclusion of at least 24 months - Signed informed consent - Patient affiliated to a social security system Exclusion Criteria: - Patients with a Rankin score before stroke than or equal to 3 - Stroke in multiple territories (contralateral carotid and / or vertebrobasilar) associated with stroke in the acute phase describing which in the opinion of the investigator significantly influence the long-term functional prognosis - Cognitive deterioration or severe aphasia making it impossible to fill out questionnaires - Minors - Major under curators

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Angers Angers
France CHU de Brest Brest
France CH R U Pontchaillou Rennes
France CHU Bretonneau Tours

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy. at least two years
Secondary To evaluate the quality of life in the physical and psychosocial domains at least two years
Secondary To evaluate the evolution of functional disability At 3 months, 12 months and 24 months.
Secondary To evaluate the life satisfaction at least two years
Secondary To assess the rate of recovery work at least two years
Secondary To evaluate the retrospective review of patients achieving craniectomy at least two years
Secondary To determine the prognostic factors that influence the level of handicap and quality of life in the long term. at least two years
Secondary To evaluate the quality of life and level of long-term care accompanying persons caring for the near a victim of malignant sylvian ischemic stroke who received a decompressive craniotomy. at least two years
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