Clinical trial NCT02320539: MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
Official title: MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Delayed Cerebral Ischemia
Acute Lung Injury
Cardiac Dysfunction
Systemic Inflammatory Response Syndrome
Keywords: MicroRNA
Cerebrospinal fluid
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delayed Cerebral Ischemia
timeFrame: 21 days
measure: Delayed Cerebral Ischemia and Cerebral infarction
timeFrame: 21 days
measure: Delayed Cerebral infarction
timeFrame: 21 days
Secondary outcomes:
measure: Acute Lung Injury
timeFrame: 21 days
measure: Cardiac Dysfunction
timeFrame: 21 days
measure: Systemic Inflammatory Response Syndrome
timeFrame: 21 days
measure: Early Brain Injury
timeFrame: Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet
name: Kirsten Møller, Prof
role: STUDY_DIRECTOR
References:
citation: Matzen JS, Krogh CL, Forman JL, Garred P, Moller K, Bache S. Lectin complement pathway initiators after subarachnoid hemorrhage - an observational study. J Neuroinflammation. 2020 Nov 12;17(1):338. doi: 10.1186/s12974-020-01979-y.