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NCT Number: NCT02320539

MicroRNA Diagnostics in Subarachnoid Hemorrhage 2

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2014
Registry last updated
May 27, 2015

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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