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Trial record 47 of 195 for:    Hemorrhage AND SAH

MicroRNA Diagnostics in Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT01791257
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : April 8, 2014
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Søren Bache Larsen, MD, Rigshospitalet, Denmark

Brief Summary:
The purpose of this study is to compare the profile of microRNA in cerebrospinal fluid from patients suffering subarachnoid hemorrhage with and without delayed cerebral ischemia.

Condition or disease
Subarachnoid Hemorrhage

Detailed Description:

In this study of patients suffering an aneurysmal subarachnoid hemorrhage (SAH) we would like to investigate the pathophysiological mechanisms that lead to the phenomenon delayed cerebral ischemia (DCI).

We will accomplish this through analyzing the profile of microRNA expression in the cerebrospinal fluid of SAH patients treated with extraventricular drainage.

At first we wish to compare the expression of 376 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.

Secondly specific microRNAs of interest in which the expression differs between group 1 and 2 are analyzed daily to investigate the dynamic changes in expression and compared to the clinical course.

Should we find no differently expressed specific microRNAs we will compare the expression of microRNA in group 1+2 with group 3.

In addition, some of the patients as part of another clinical trial (NCT01447095

) will have established invasive neuromonitoring including microdialysis. It is our intention to develop a method for analyzing microRNA in this microdialysate.

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."


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Study Type : Observational [Patient Registry]
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: MicroRNA Expression in Cerebrospinal Fluid From Patients Suffering Subarachnoid Hemorrhage With and Without Delayed Cerebral Ischemia
Study Start Date : February 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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.
Neurological healthy controls
12 patients (ASA 1) undergoing spinal anesthesia for orthopedic surgery have 2 ml of cerebrospinal fluid drawn preceding injection of local analgetic.



Primary Outcome Measures :
  1. Delayed Cerebral Ischemia - Clean groups [ Time Frame: 21 days ]

    Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.

    We found confirmation/exclusion of DCI difficult in a few patients. To minimize error, two clinicians reviewed all clinical, biochemical and radiological data, obtained 3 weeks from ictus, and independently assessed if any clinical deterioration fulfilled the criteria of delayed cerebral ischemia. Furthermore, included patients were categorized as "definitely DCI", "probably DCI", "probably not DCI" or "definitely not DCI".

    Therefore we decided to modify our primary outcome measure in this case-control study to compare "definitely DCI" vs. "definitely not DCI".



Secondary Outcome Measures :
  1. Early brain injury: Comparison of microRNA profiles with clinical neurology following occlusion of the aneurysm [ Time Frame: Assessed at the first wake-up call following clip or coil ]

    Comparison of 667 specific microRNAs in CSF at day 5 after ictus between two groups of SAH-patients depending on their clinical neurology at the first wake-up call following occlusion of the aneurysm:

    1. GCS 3-12 and/or (paresis (degree 4) of at least one extremity or aphasia)
    2. GCS 13-15 and no or only small and mild focal deficit

  2. Association of microRNA-profile with 3 month outcome [ Time Frame: Follow up examination at 3 month or as close to this ]

    Comparison of 667 specific microRNAs in CSF at day 5 after ictus between two groups of SAH-patients depending on their mRS at 3 month follow-up in groups:

    1. mRS = 3-6
    2. mRS = 0-2

  3. Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Large groups. [ Time Frame: 21 days following ictus ]

    Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395.

    In contrast to our primary outcome measure, these groups will include patients where DCI was difficult to exclude or confirm.

    Thereby we wish to compare "definitely DCI" and "probably DCI" vs. "probably not DCI" and "definetly not DCI". This would enable comparison between larger groups though less clean.


  4. Relation of microRNA profile to cerebral infarction as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. [ Time Frame: Following a blinded description of CT-scans ]
    The presence of cerebral infarction on CT or MR scan of the brain within 6 weeks after SAH, or on the latest CT or MR scan made before death within 6 weeks, or proven at autopsy, not present on the CT or MR scan between 24 and 48 hours after early aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities on CT imaging resulting from ventricular catheter or intraparenchymal hematoma should not be regarded as cerebral infarctions from DCI.

  5. Relation of microRNA profile to the regional area of cerebral injury [ Time Frame: Following a blinded description of CT-scans ]
    As microRNAs seem to be specific for different areas of the brain our screening might tell us which area has sustained injury and which has not. This study will not include two groups as the secondary outcome measures above.


Biospecimen Retention:   Samples With DNA
Group 1+2: Cerebrospinal fluid 1-2 ml a day for 8 days drawn in each patient from external ventricular drain Gropu 3: Cerebrospinal fluid 2 ml drawn from patients undergoing spinal anesthesia before injection of local anesthetic.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Group 1+2: Patients admitted to Neurointensive Department in Rigshospitalet. Group 3: Patients undergoing spinal anesthesia for orthopedic surgery in Bispebjerg Hospital.
Criteria

Inclusion Criteria:

  • Patient admitted to the neurointensive care unit with aneurismal subarachnoid hemorrhage
  • External ventricular drainage with 5 days of ictus
  • Age > 18 years

Exclusion Criteria:

  • Glasgow Coma Score (GCS) continuously < 7 during the first 5 days following ictus
  • A known and proven complication (rebleeding, clip/coil complication, cardiopulmonal complication requiring full sedation, ventriculitis e.g.) leads to a GCS < 7 thereby preventing the detection of DCI.

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): NCT01791257


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 1302
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Rigshospitalet, Denmark
Bispebjerg Hospital
Investigators
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Principal Investigator: Søren B Larsen, MD Rigshopsitalet, Denmark
Study Chair: Kirsten Møller, DMSci Rigshospitalet, Denmark

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Søren Bache Larsen, MD, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01791257     History of Changes
Other Study ID Numbers: MicroRNA in SAH
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

Keywords provided by Søren Bache Larsen, MD, Rigshospitalet, Denmark:
delayed
cerebral
ischemia
microrna
cerebrospinal fluid
subarachnoid
hemorrhage

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases