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Craniectomy Protocol

N

Nantes University Hospital (NUH)

Status

Completed

Conditions

Ischemic Stroke
Decompressive Craniectomy

Study type

Observational

Funder types

Other

Identifiers

NCT01990014
BRD/10/08-I

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

62 participants in 1 patient group

craniectomy
Description:
Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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