MicroRNA Diagnostics in Subarachnoid Hemorrhage 2

Completed

• Conditions: Subarachnoid Hemorrhage; Delayed Cerebral Ischemia; Systemic Inflammatory Response Syndrome; Acute Lung Injury; Cardiac Dysfunction

• Registration Number: NCT02320539
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Study Timeline

• Study First Submitted: 2014-10-28
• Study Start: 2014-11
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-25
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delayed Cerebral Ischemia	21 days	Delayed Cerebral Ischemia as defined by Vergouwen et al\[1\]. In our earlier study we found the clinical condition DCI somehow subjective which is why we added the following two primary outcome measures.; Comparing microRNA profiles between groups with or without.
Delayed Cerebral infarction	21 days	as defined by Vergouwen et al \[1\].; Comparing microRNA profiles between groups with or without.
Delayed Cerebral Ischemia and Cerebral infarction	21 days	as defined by Vergouwen et al \[1\].; Comparing microRNA profiles between groups with or without.

Secondary Outcome Measures

Name	Time	Method
Acute Lung Injury	21 days	as defined by Kahn et al\[2\].; Comparing microRNA profiles between groups with or without
Systemic Inflammatory Response Syndrome	21 days	Evaluated through daily vital signs and biochemistry; Comparing microRNA profiles between groups with or without
Early Brain Injury	Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)	Early Brain injury = GCS 3-12 and/or paresis (degree 4) of at least one extremity or aphasia No Early Brain injury = GCS 13-15 and no or only small and mild focal deficit; Comparing microRNA profiles between groups with or without
Cardiac Dysfunction	21 days	Evaluated by transthoracic echocardiography; Comparing microRNA profiles between groups with or without

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark