MicroRNA Diagnostics in Subarachnoid Hemorrhage
Keywords
Abstract
Description
In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to investigate the pathophysiological mechanisms that lead to the phenomenon delayed cerebral ischemia (DCI).
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."
Dates
| Last Verified: | 03/31/2014 |
| First Submitted: | 02/11/2013 |
| Estimated Enrollment Submitted: | 02/11/2013 |
| First Posted: | 02/12/2013 |
| Last Update Submitted: | 04/06/2014 |
| Last Update Posted: | 04/07/2014 |
| Actual Study Start Date: | 01/31/2013 |
| Estimated Primary Completion Date: | 12/31/2013 |
| Estimated Study Completion Date: | 12/31/2013 |
Condition or disease
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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. | |
| 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. | |
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. Delayed Cerebral Ischemia - Clean groups [21 days]
Secondary Outcome Measures
1. Early brain injury: Comparison of microRNA profiles with clinical neurology following occlusion of the aneurysm [Assessed at the first wake-up call following clip or coil]
2. Association of microRNA-profile with 3 month outcome [Follow up examination at 3 month or as close to this]
3. Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Large groups. [21 days following ictus]
4. Relation of microRNA profile to cerebral infarction as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. [Following a blinded description of CT-scans]
5. Relation of microRNA profile to the regional area of cerebral injury [Following a blinded description of CT-scans]
