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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03186157 |
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Date of registration:
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11/06/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevalence of Trephined Syndrome After Decompressive Craniectomy
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Scientific title:
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A Prospective Observational Study on Risk Factors of Developing and Prevalence of Trephined Syndrome in Patients After Hemispheric Decompressive Craniectomy and Effect of Cranioplasty on Functional and Cognitive Recovery |
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Date of first enrolment:
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January 16, 2012 |
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Target sample size:
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41 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03186157 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Switzerland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with decompressive craniectomy for intracranial hypertension secondary to
stroke, traumatic brain injury or other non-progressive cerebral pathology.
Exclusion Criteria:
- patients suffering from a rapidly evolving cerebral pathology (e.g. tumor)
- patients transferred to other hospitals before cranioplasty or whose follow-up can not
be assured.
Age minimum:
14 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Post Operative Hemorrhage
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Traumatic Brain Injury
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Trephined Syndrome
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Post-Op Complication
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Post-Op Infection
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Stroke
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Sinking Skin Flap Syndrome
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Intervention(s)
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Procedure: Decompressive craniectomy
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Procedure: Cranioplasty
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Primary Outcome(s)
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Presence of Trephined Syndrome
[Time Frame: From patients admission to discharge from rehabilitation (approx. 3 months).]
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Secondary Outcome(s)
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Complications related to cranioplasty
[Time Frame: From patients admission to discharge from rehabilitation (approx. 3 months).]
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Relation of delay to cranioplasty with neurological outcome
[Time Frame: From patients admission to discharge from rehabilitation (approx. 3 months).]
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Relation of delay to cranioplasty with complications post-cranioplasty
[Time Frame: From patients admission to discharge from rehabilitation (approx. 3 months).]
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Secondary ID(s)
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CER 11-234 (NAC 11-086)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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