MicroRNA Diagnostics in Subarachnoid Hemorrhage 2

Subarachnoid Hemorrhage Clinical Trial

Official title:

MicroRNA Diagnostics in Subarachnoid Hemorrhage 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320539
• Other study ID #: H-6-2014-073
• Status: Completed
• Phase: N/A
• First received: October 28, 2014
• Last updated: May 25, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish Data Protection AgencyDenmark: Danish Health and Medicines AuthorityDenmark: Danish Regional Scientific Ethics Committee of the Capital Region
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria Group 1-3:

• Uncertainty < 24 times on time of ictus

Inclusion Criteria Group 1-2:

• Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated with external ventricular drain.

Inclusion Criteria Group 3:

• Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated without external ventricular drain.

Exclusion Criteria Group 1-3:

• Transfer to other hospital within 5 days of admission

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Cardiac Dysfunction
• Cerebral Infarction
• Delayed Cerebral Ischemia
• Hemorrhage
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Subarachnoid Hemorrhage
• Systemic Inflammatory Response Syndrome

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed Cerebral Ischemia	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.	21 days	No
Primary	Delayed Cerebral Ischemia and Cerebral infarction	as defined by Vergouwen et al [1].; Comparing microRNA profiles between groups with or without.	21 days	No
Primary	Delayed Cerebral infarction	as defined by Vergouwen et al [1].; Comparing microRNA profiles between groups with or without.	21 days	No
Secondary	Acute Lung Injury	as defined by Kahn et al[2].; Comparing microRNA profiles between groups with or without	21 days	No
Secondary	Cardiac Dysfunction	Evaluated by transthoracic echocardiography; Comparing microRNA profiles between groups with or without	21 days	No
Secondary	Systemic Inflammatory Response Syndrome	Evaluated through daily vital signs and biochemistry; Comparing microRNA profiles between groups with or without	21 days	No
Secondary	Early Brain Injury	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	Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)	No

External Links

•   [1] Vergouwen et al in Stroke 2010;41(10):2391-2395.
•   [2] Kahn et al, Crit Care Med, Vol. 34, No.1 2006