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MicroRNA Diagnostics in Subarachnoid Hemorrhage 2

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ClinicalTrials.gov Identifier: NCT02320539
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Søren Bache, MD, 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.

Condition or disease
Subarachnoid Hemorrhage Delayed Cerebral Ischemia Acute Lung Injury Cardiac Dysfunction Systemic Inflammatory Response Syndrome

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 Type : Observational [Patient Registry]
Actual Enrollment : 70 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
Study Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Group/Cohort
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.
SAH good grade
SAH without external ventricular drainage
Healthy controls
Blood sample in healthy donors registered in the National Donor Registry.



Primary Outcome Measures :
  1. Delayed Cerebral Ischemia [ Time Frame: 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.


  2. Delayed Cerebral Ischemia and Cerebral infarction [ Time Frame: 21 days ]

    as defined by Vergouwen et al [1].

    Comparing microRNA profiles between groups with or without.


  3. Delayed Cerebral infarction [ Time Frame: 21 days ]

    as defined by Vergouwen et al [1].

    Comparing microRNA profiles between groups with or without.



Secondary Outcome Measures :
  1. Acute Lung Injury [ Time Frame: 21 days ]

    as defined by Kahn et al[2].

    Comparing microRNA profiles between groups with or without


  2. Cardiac Dysfunction [ Time Frame: 21 days ]

    Evaluated by transthoracic echocardiography

    Comparing microRNA profiles between groups with or without


  3. Systemic Inflammatory Response Syndrome [ Time Frame: 21 days ]

    Evaluated through daily vital signs and biochemistry

    Comparing microRNA profiles between groups with or without


  4. Early Brain Injury [ Time Frame: 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



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320539


Locations
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Kirsten Møller, Prof Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet

Additional Information:
Responsible Party: Søren Bache, MD, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02320539     History of Changes
Other Study ID Numbers: H-6-2014-073
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by Søren Bache, MD, Rigshospitalet, Denmark:
MicroRNA
Cerebrospinal fluid

Additional relevant MeSH terms:
Hemorrhage
Ischemia
Subarachnoid Hemorrhage
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Systemic Inflammatory Response Syndrome
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders
Inflammation
Shock
Brain Infarction
Stroke