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CompletedNCT01990014Updated Sep 10, 2021

Craniectomy Protocol

An observational study in Ischemic Stroke and Decompressive Craniectomy, sponsored by Nantes University Hospital. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-10.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
62
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Ischemic Stroke
  • Decompressive Craniectomy

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's enrollment of 62 is below the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • craniectomy

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

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What researchers measure

Primary outcomes

  1. To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.

    Time frame: at least two years

Secondary outcomes

  1. To evaluate the quality of life in the physical and psychosocial domains

    Time frame: at least two years

  2. To evaluate the evolution of functional disability

    Time frame: At 3 months, 12 months and 24 months.

  3. To evaluate the life satisfaction

    Time frame: at least two years

  4. To assess the rate of recovery work

    Time frame: at least two years

  5. To evaluate the retrospective review of patients achieving craniectomy

    Time frame: at least two years

  6. To determine the prognostic factors that influence the level of handicap and quality of life in the long term.

    Time frame: at least two years

  7. 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.

    Time frame: at least two years

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Study locations

4 sites
  • CHU Angers
    Angers, France
  • CHU de Brest
    Brest, France
  • CH R U Pontchaillou
    Rennes, France
  • CHU Bretonneau
    Tours, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01990014
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Nov 21, 2013
Start date
Jun 2011
Primary completion
Feb 2013
Completion
Jul 2013
Last update
Sep 10, 2021

Study contacts

SÉVIN ALLOUET Mathieu, Dr
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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