Subarachnoid Hemorrhage Clinical Trial
Official title:
MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications.
In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would
like to validate former results from CSF studies through microRNA profiling investigate the
pathophysiological mechanisms that lead to systemic complications such as cardiac
dysfunction, acute lung injury (ALI) and systemic inflammatory response syndrome(SIRS).
We will accomplish this through analyzing the profile of microRNA expression in blood and
cerebrospinal fluid from SAH patients.
Validation:
As in our earlier study we wish to compare the expression of 20 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. In addition, some of the patients will have established
invasive neuromonitoring including microdialysis in which we will study changes of certain
microRNAs.
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."
Systemic complications:
Furthermore, we wish to compare the expression of 754 specific microRNA in blood drawn on
day 3 after ictus between patients with ALI (as described Kahn et al, Crit Care Med. 2006;
34: 196-202) and patients without ALI. Of at least 36 patients expected to be included 12
should statistically develop ALI according to the referred definition.
Additionally, we wish to compare the expression of 754 specific microRNA between 12 patients
developing DCI (group 1) and 12 patients without DCI (group 2) in blood drawn on day 3 after
ictus.
Moreover, we wish to compare the expression of 754 specific microRNA in blood between 36
patients (group 1-3) to that of healthy controls. The specific microRNAs of interest in
which the expression in blood between patients with systemic complication are analyzed daily
to investigate the dynamic changes in expression and compared to the clinical course.
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Observational Model: Case Control, Time Perspective: Prospective
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