MicroRNA Diagnostics in Subarachnoid Hemorrhage 2

Completed

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Trial Design

  • Observation: Case Control
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

Group 1-2: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated with external ventricular drain. Group 3: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated without external ventricular drain. Group 4: Healthy blood donors

Outcomes

Type Measure Time Frame Safety Issue
Primary Delayed Cerebral Ischemia 21 days No
Primary Delayed Cerebral Ischemia and Cerebral infarction 21 days No
Primary Delayed Cerebral infarction 21 days No
Secondary Acute Lung Injury 21 days No
Secondary Cardiac Dysfunction 21 days No
Secondary Systemic Inflammatory Response Syndrome 21 days No
Secondary Early Brain Injury Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated) No

Biospecimen Retention:Samples With DNA - MicroRNA profiles from blood and cerebrospinal fluid are investigated.

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