Study Results
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Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2013-02-28
2014-01-31
Brief Summary
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Detailed Description
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We will accomplish this through analyzing the profile of microRNA expression in the cerebrospinal fluid of SAH patients treated with extraventricular drainage.
At first we wish to compare the expression of 376 specific microRNA between 12 patients developing DCI (group 1) and 12 patients without DCI (group 2) in cerebrospinal fluid drawn on day 5 after ictus.
Secondly specific microRNAs of interest in which the expression differs between group 1 and 2 are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.
Should we find no differently expressed specific microRNAs we will compare the expression of microRNA in group 1+2 with group 3.
In addition, some of the patients as part of another clinical trial (NCT01447095
) will have established invasive neuromonitoring including microdialysis. It is our intention to develop a method for analyzing microRNA in this microdialysate.
DCI as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395:
"The occurrence of focal neurological impairment (such as hemiparesis, aphasia, apraxia, hemianopia, or neglect), or a decrease of at least 2 points on the Glasgow Coma Scale (either on the total score or on one of its individual components \[eye, motor on either side, verbal\]). This should last for at least 1 hour, is not apparent immediately after aneurysm occlusion, and cannot be attributed to other causes by means of clinical assessment, CT or MRI scanning of the brain, and appropriate laboratory studies."
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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SAH with DCI
After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.
No interventions assigned to this group
SAH without DCI
After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.
No interventions assigned to this group
Neurological healthy controls
12 patients (ASA 1) undergoing spinal anesthesia for orthopedic surgery have 2 ml of cerebrospinal fluid drawn preceding injection of local analgetic.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* External ventricular drainage with 5 days of ictus
* Age \> 18 years
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Søren Bache Larsen, MD
MD
Principal Investigators
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Søren B Larsen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshopsitalet, Denmark
Kirsten Møller, DMSci
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Countries
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References
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Matzen JS, Krogh CL, Forman JL, Garred P, Moller K, Bache S. Lectin complement pathway initiators after subarachnoid hemorrhage - an observational study. J Neuroinflammation. 2020 Nov 12;17(1):338. doi: 10.1186/s12974-020-01979-y.
Bache S, Rasmussen R, Rossing M, Laigaard FP, Nielsen FC, Moller K. MicroRNA Changes in Cerebrospinal Fluid After Subarachnoid Hemorrhage. Stroke. 2017 Sep;48(9):2391-2398. doi: 10.1161/STROKEAHA.117.017804. Epub 2017 Aug 2.
Other Identifiers
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MicroRNA in SAH
Identifier Type: -
Identifier Source: org_study_id
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