Das Subnetz „Klinische Studien“ im Kompetenznetz Schlaganfall

G. Thomalla; M. Siebler; C. Dohmen; J. P. Dreier; R. Graf; J. Röther

doi:10.1055/s-0038-1626799

Nervenheilkunde, Table of Contents

Nervenheilkunde 2006; 25(11): 911-918
DOI: 10.1055/s-0038-1626799

Originaler Artikel

Schattauer GmbH

Das Subnetz „Klinische Studien“ im Kompetenznetz Schlaganfall

Eine erfolgreiche Plattform für die Durchführung multizentrischer klinischer StudienThe „Clinical Trial Net“ within the German Competence Net StrokeAn effective platform for the realisation of clinical multicentre studies

G. Thomalla

¹Klinik und Poliklinik für Neurologie, NeuroZentrum, Universitätsklinikum Hamburg-Eppendorf (Direktor: Prof. Dr. C. Gerloff)

,

M. Siebler

²Neurologische Klinik, Universitätsklinikum Düsseldorf (Direktor: Prof. Dr. H.-P. Hartung)

,

C. Dohmen

³Max-Planck-Institut für Neurologische Forschung Köln (Direktor: Prof. Dr. Y. von Cramon)

,

J. P. Dreier

⁴Klinik für Neurologie, Charité Berlin (Direktor: Prof. Dr. K. M. Einhäupl)

,

R. Graf

³Max-Planck-Institut für Neurologische Forschung Köln (Direktor: Prof. Dr. Y. von Cramon)

,

J. Röther

⁵Neurologische Klinik, Klinikum Minden, Universität Hannover (Chefarzt: Prof. Dr. J. Röther)

› Author Affiliations

Abstract

Zusammenfassung

Im Subnetz „Klinische Studien“ des Kompetenznetzes Schlaganfall werden multizentrische klinische Studien zum akuten Schlaganfall koordiniert und durchgeführt. Studien über die Sicherheit und Effektivität der akuten Schlaganfallbehandlung mit dem Glykoprotein IIb/IIIa-Rezeptorantagonisten Tirofiban zeigen erfolgversprechende Ansätze zur verbesserten Akuttherapie und bilden die Basis für Zulassungsstudien. In einer großen multizentrischen Studie konnte gezeigt werden, dass die intravenöse Thrombolyse mit tPA im erweiterten Zeitfenster bis sechs Stunden nach Symptombeginn bei mittels MRT-Kriterien ausgewählten Patienten sicher und effektiv ist. In einer aktuellen Studie wird untersucht, ob die multimodale MRT-Bildgebung bereits in der Akutphase die zuverlässige Identifikation von Risikopatienten für die Entwicklung eines malignen Mediainfarktes ermöglicht. Erste Ergebnisse der noch laufenden COSBID-Studie haben gezeigt, dass Periinfarkt-Depolarisationen bei malignem Mediainfarkt, Subarachnoidalblutung und intrakranieller Blutung auftreten. Im weiteren Verlauf der Studie wird die klinische Relevanz dieser transienten Depolarisationen als wesentliches Merkmal der Sekundärschädigung bei den genannten Krankheitsbildern überprüft. Insgesamt hat die Kooperation mehrerer Schlaganfallzentren in einem multizentrischen Ansatz im Subnetz „Klinische Studien“ die Durchführung von Studien ermöglicht, welche in einzelnen Zentren in dieser Form nicht zu realisieren gewesen wären.

Summary

Within the Clinical Trial Net of the German Competence Net Stroke, clinical multicenter trials involving acute stroke patients are coordinated and conducted. Studies of safety and efficacy of the GP IIb/IIIa receptor antagonist Tirofiban in acute stroke treatment have been promising and hopefully result in approval studies for Tirofiban for acute stroke treatment. In a prospective multicentre study it was shown that intravenous thrombolysis with tPA within an expanded time window of up to six hours is safe and effective in MRI selected patients. An ongoing study is conducted to verify that acute stroke MRI allows the identification of patients at risk of developing malignant middle cerebral artery infarction. Preliminary results of the COSBID study have demonstrated periinfarct depolarisation in malignant middle cerebral artery infarction, subarachnoid haemorrhage and intracranial haemorrhage. Now, the ongoing study aims to verify the impact of these spreading depressions for the secondary damage in these diseases. To summarize, the cooperation of several stroke centres within the Clinical Trial Net has enabled stroke researchers to perform studies, which could not have been realized in a single centre approach.

Schlüsselwörter

Akuter Schlaganfall - multizentrische Studien - Tirofiban - Thrombolyse - Perfusion-/Diffusions-MRT - Periinfarkt-Depolarisation

Keywords

Acute stroke - multicenter studies - Tirofiban - thrombolysis - diffusion-/perfusion-weighted MRI - peri-infarct depolarisation

Full Text

References

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