- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02320539
MicroRNA Diagnostics in Subarachnoid Hemorrhage 2
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Copenhagen, Dänemark, 2100
- Rigshospitalet
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Fallkontrolle
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
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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.
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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.
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SAH good grade
SAH without external ventricular drainage
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Healthy controls
Blood sample in healthy donors registered in the National Donor Registry.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Delayed Cerebral Ischemia
Zeitfenster: 21 days
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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
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Delayed Cerebral Ischemia and Cerebral infarction
Zeitfenster: 21 days
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as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. |
21 days
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Delayed Cerebral infarction
Zeitfenster: 21 days
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as defined by Vergouwen et al [1]. Comparing microRNA profiles between groups with or without. |
21 days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Acute Lung Injury
Zeitfenster: 21 days
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as defined by Kahn et al[2]. Comparing microRNA profiles between groups with or without |
21 days
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Cardiac Dysfunction
Zeitfenster: 21 days
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Evaluated by transthoracic echocardiography Comparing microRNA profiles between groups with or without |
21 days
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Systemic Inflammatory Response Syndrome
Zeitfenster: 21 days
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Evaluated through daily vital signs and biochemistry Comparing microRNA profiles between groups with or without |
21 days
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Early Brain Injury
Zeitfenster: Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)
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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)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Kirsten Møller, Prof, Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Nekrose
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Erkrankungen der Atemwege
- Lungenkrankheit
- Entzündung
- Wunden und Verletzungen
- Schock
- Infarkt
- Streicheln
- Hirninfarkt
- Intrakranielle Blutungen
- Thoraxverletzungen
- Ischämie des Gehirns
- Ischämie
- Blutung
- Hirninfarkt
- Subarachnoidalblutung
- Akute Lungenverletzung
- Lungenverletzung
- Systemisches Entzündungsreaktionssyndrom
Andere Studien-ID-Nummern
- H-6-2014-073
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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