Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Delayed Cerebral Ischemia and Cerebral infarction | as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. | 21 days |
| Delayed Cerebral infarction | as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Lung Injury | as defined by Kahn et al[2]. Comparing microRNA profiles between groups with or without | 21 days |
| Cardiac Dysfunction | Evaluated by transthoracic echocardiography Comparing microRNA profiles between groups with or without |
Not provided
Inclusion Criteria Group 1-3:
Inclusion Criteria Group 1-2:
Inclusion Criteria Group 3:
Exclusion Criteria Group 1-3:
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kirsten Møller, Prof | Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33183322 | Derived | 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. |
| Label | URL |
|---|---|
| \[1\] Vergouwen et al in Stroke 2010;41(10):2391-2395. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D055371 | Acute Lung Injury |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
MicroRNA profiles from blood and cerebrospinal fluid are investigated.
| 21 days |
| Systemic Inflammatory Response Syndrome | Evaluated through daily vital signs and biochemistry Comparing microRNA profiles between groups with or without | 21 days |
| 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) |
| \[2\] Kahn et al, Crit Care Med, Vol. 34, No.1 2006 | View source |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007249 | Inflammation |
| D012769 | Shock |