Craniectomy Protocol

Ischemic Stroke Clinical Trial

Official title:

Multicenter Clinical Study Evaluating the Functional Prognosis and Quality of Life at Least 2 Years in Patients Treated With Decompressive Craniectomy for Malignant Sylvian Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990014
• Other study ID #: BRD/10/08-I
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Decompressive Craniectomy
• Ischemia
• Ischemic Stroke
• Stroke

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