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MicroRNA Diagnostics in Subarachnoid Hemorrhage

7. April 2014 aktualisiert von: Søren Bache Larsen, MD, Rigshospitalet, Denmark

MicroRNA Expression in Cerebrospinal Fluid From Patients Suffering Subarachnoid Hemorrhage With and Without Delayed Cerebral Ischemia

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Subarachnoidalblutung

Detaillierte Beschreibung

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."

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Dänemark
- - Copenhagen, Dänemark, 2400
    - Bispebjerg Hospital
  - Copenhagen, Dänemark, 1302
    - Rigshospitalet

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Group 1+2: Patients admitted to Neurointensive Department in Rigshospitalet. Group 3: Patients undergoing spinal anesthesia for orthopedic surgery in Bispebjerg Hospital.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Delayed Cerebral Ischemia - Clean groups Zeitfenster: 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".	21 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Early brain injury: Comparison of microRNA profiles with clinical neurology following occlusion of the aneurysm Zeitfenster: 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: GCS 3-12 and/or (paresis (degree 4) of at least one extremity or aphasia) GCS 13-15 and no or only small and mild focal deficit	Assessed at the first wake-up call following clip or coil
Association of microRNA-profile with 3 month outcome Zeitfenster: 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: mRS = 3-6 mRS = 0-2	Follow up examination at 3 month or as close to this
Delayed Cerebral Ischemia as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Large groups. Zeitfenster: 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.	21 days following ictus
Relation of microRNA profile to cerebral infarction as defined by Vergouwen et al in Stroke 2010;41(10):2391-2395. Zeitfenster: 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.	Following a blinded description of CT-scans
Relation of microRNA profile to the regional area of cerebral injury Zeitfenster: 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.	Following a blinded description of CT-scans

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rigshospitalet, Denmark

Mitarbeiter

Bispebjerg Hospital

Ermittler

Hauptermittler: Søren B Larsen, MD, Rigshopsitalet, Denmark
Studienstuhl: Kirsten Møller, DMSci, Rigshospitalet, Denmark

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Februar 2013

Primärer Abschluss (Tatsächlich)

1. Januar 2014

Studienabschluss (Tatsächlich)