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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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19 February 2015 |
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Main ID: |
NCT01791257 |
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Date of registration:
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12/02/2013 |
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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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MicroRNA Diagnostics in Subarachnoid Hemorrhage
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Scientific title:
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MicroRNA Expression in Cerebrospinal Fluid From Patients Suffering Subarachnoid Hemorrhage With and Without Delayed Cerebral Ischemia |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01791257 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Søren B Larsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshopsitalet, Denmark |
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Name:
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Kirsten Møller, DMSci |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient admitted to the neurointensive care unit with aneurismal subarachnoid
hemorrhage
- External ventricular drainage with 5 days of ictus
- Age > 18 years
Exclusion Criteria:
- Glasgow Coma Score (GCS) continuously < 7 during the first 5 days following ictus
- A known and proven complication (rebleeding, clip/coil complication, cardiopulmonal
complication requiring full sedation, ventriculitis e.g.) leads to a GCS < 7 thereby
preventing the detection of DCI.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Subarachnoid Hemorrhage
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Primary Outcome(s)
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Delayed Cerebral Ischemia - Clean groups
[Time Frame: 21 days]
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Secondary Outcome(s)
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Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Large groups.
[Time Frame: 21 days following ictus]
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Association of microRNA-profile with 3 month outcome
[Time Frame: Follow up examination at 3 month or as close to this]
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Early brain injury: Comparison of microRNA profiles with clinical neurology following occlusion of the aneurysm
[Time Frame: Assessed at the first wake-up call following clip or coil]
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Relation of microRNA profile to the regional area of cerebral injury
[Time Frame: Following a blinded description of CT-scans]
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Relation of microRNA profile to cerebral infarction as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.
[Time Frame: Following a blinded description of CT-scans]
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Secondary ID(s)
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MicroRNA in SAH
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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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