Hemorrhage Clinical Trial
Official title:
Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery
| Verified date | April 2010 |
| Source | Nycomed |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Observational |
Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and support speech-nerve saving approaches. The aim of this study was to evaluate a patient and procedure profile where TachoSil® is most beneficial.
| Status | Completed |
| Enrollment | 482 |
| Est. completion date | January 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Main Inclusion Criteria: - Patients undergoing total or subtotal thyroidectomy Main Exclusion Criteria: - Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Nycomed Deutschland GmbH | Aschaffenburg | |
| Germany | Nycomed Deutschland GmbH | Aschersleben | |
| Germany | Nycomed Deutschland GmbH | Bad Berka | |
| Germany | Nycomed Deutschland GmbH | Bad Salzungen | |
| Germany | Nycomed Deutschland GmbH | Bad Tölz | |
| Germany | Nycomed Deutschland GmbH | Baden-Baden | |
| Germany | Nycomed Deutschland GmbH | Bayreuth | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Berlin | |
| Germany | Nycomed Deutschland GmbH | Bielefeld | |
| Germany | Nycomed Deutschland GmbH | Bielefeld | |
| Germany | Nycomed Deutschland GmbH | Bischofswerda | |
| Germany | Nycomed Deutschland GmbH | Bochum | |
| Germany | Nycomed Deutschland GmbH | Bonn | |
| Germany | Nycomed Deutschland GmbH | Bottrop | |
| Germany | Nycomed Deutschland GmbH | Braunschweig | |
| Germany | Nycomed Deutschland GmbH | Bruchsal | |
| Germany | Nycomed Deutschland GmbH | Chemnitz | |
| Germany | Nycomed Deutschland GmbH | Coswig | |
| Germany | Nycomed Deutschland GmbH | Cottbus | |
| Germany | Nycomed Deutschland GmbH | Deggendorf | |
| Germany | Nycomed Deutschland GmbH | Detmold | |
| Germany | Nycomed Deutschland GmbH | Dinkelsbühl | |
| Germany | Nycomed Deutschland GmbH | Dortmund | |
| Germany | Nycomed Deutschland GmbH | Duisburg | |
| Germany | Nycomed Deutschland GmbH | Düsseldorf | |
| Germany | Nycomed Deutschland GmbH | Düsseldorf | |
| Germany | Nycomed Deutschland GmbH | Düsseldorf | |
| Germany | Nycomed Deutschland GmbH | Eberswalde | |
| Germany | Nycomed Deutschland GmbH | Eckernförde | |
| Germany | Nycomed Deutschland GmbH | Eichsfeld | |
| Germany | Nycomed Deutschland GmbH | Eisenach | |
| Germany | Nycomed Deutschland GmbH | Erfurt | |
| Germany | Nycomed Deutschland GmbH | Erlangen | |
| Germany | Nycomed Deutschland GmbH | Essen | |
| Germany | Nycomed Deutschland GmbH | Essen | |
| Germany | Nycomed Deutschland GmbH | Frankfurt | |
| Germany | Nycomed Deutschland GmbH | Frankfurt (Oder) | |
| Germany | Nycomed Deutschland GmbH | Frechen | |
| Germany | Nycomed Deutschland GmbH | Freudenstadt | |
| Germany | Nycomed Deutschland GmbH | Fürstenfeldbruck | |
| Germany | Nycomed Deutschland GmbH | Fürth | |
| Germany | Nycomed Deutschland GmbH | Gelnhausen | |
| Germany | Nycomed Deutschland GmbH | Gelsenkirchen | |
| Germany | Nycomed Deutschland GmbH | Gera | |
| Germany | Nycomed Deutschland GmbH | Göppingen | |
| Germany | Nycomed Deutschland GmbH | Görlitz | |
| Germany | Nycomed Deutschland GmbH | Gummersbach | |
| Germany | Nycomed Deutschland GmbH | Hagen | |
| Germany | Nycomed Deutschland GmbH | Halle | |
| Germany | Nycomed Deutschland GmbH | Hamburg | |
| Germany | Nycomed Deutschland GmbH | Hamburg | |
| Germany | Nycomed Deutschland GmbH | Hamburg | |
| Germany | Nycomed Deutschland GmbH | Hamburg | |
| Germany | Nycomed Deutschland GmbH | Hamburg | |
| Germany | Nycomed Deutschland GmbH | Hamm | |
| Germany | Nycomed Deutschland GmbH | Hanau | |
| Germany | Nycomed Deutschland GmbH | Hartmannsdorf | |
| Germany | Nycomed Deutschland GmbH | Hausham | |
| Germany | Nycomed Deutschland GmbH | Heilbronn | |
| Germany | Nycomed Deutschland GmbH | Heinsberg | |
| Germany | Nycomed Deutschland GmbH | Herten | |
| Germany | Nycomed Deutschland GmbH | Ibbenbüren | |
| Germany | Nycomed Deutschland GmbH | Ingolstadt | |
| Germany | Nycomed Deutschland GmbH | Jena | |
| Germany | Nycomed Deutschland GmbH | Karlsruhe | |
| Germany | Nycomed Deutschland GmbH | Karlsruhe | |
| Germany | Nycomed Deutschland GmbH | Kassel | |
| Germany | Nycomed Deutschland GmbH | Kassel | |
| Germany | Nycomed Deutschland GmbH | Köln | |
| Germany | Nycomed Deutschland GmbH | Köln-Lindenthal | |
| Germany | Nycomed Deutschland GmbH | Konstanz | |
| Germany | Nycomed Deutschland GmbH | Langen | |
| Germany | Nycomed Deutschland GmbH | Leipzig | |
| Germany | Nycomed Deutschland GmbH | Leipzig | |
| Germany | Nycomed Deutschland GmbH | Lichtenfels | |
| Germany | Nycomed Deutschland GmbH | Lohr am Main | |
| Germany | Nycomed Deutschland GmbH | Lörrach | |
| Germany | Nycomed Deutschland GmbH | Lübbecke | |
| Germany | Nycomed Deutschland GmbH | Lübeck | |
| Germany | Nycomed Deutschland GmbH | Luckenwalde | |
| Germany | Nycomed Deutschland GmbH | Magdeburg | |
| Germany | Nycomed Deutschland GmbH | Mainz | |
| Germany | Nycomed Deutschland GmbH | Mainz | |
| Germany | Nycomed Deutschland GmbH | Mannheim | |
| Germany | Nycomed Deutschland GmbH | Mannheim | |
| Germany | Nycomed Deutschland GmbH | Marburg | |
| Germany | Nycomed Deutschland GmbH | Meppen | |
| Germany | Nycomed Deutschland GmbH | Mettmann | |
| Germany | Nycomed Deutschland GmbH | München | |
| Germany | Nycomed Deutschland GmbH | Münster | |
| Germany | Nycomed Deutschland GmbH | Münster | |
| Germany | Nycomed Deutschland GmbH | Neu-Ulm | |
| Germany | Nycomed Deutschland GmbH | Neumarkt in der Oberpfalz | |
| Germany | Nycomed Deutschland GmbH | Neumünster | |
| Germany | Nycomed Deutschland GmbH | Neuruppin | |
| Germany | Nycomed Deutschland GmbH | Nordhausen | |
| Germany | Nycomed Deutschland GmbH | Nürnberg | |
| Germany | Nycomed Deutschland GmbH | Oberhausen | |
| Germany | Nycomed Deutschland GmbH | Oldenburg | |
| Germany | Nycomed Deutschland GmbH | Oldenburg | |
| Germany | Nycomed Deutschland GmbH | Pforzheim | |
| Germany | Nycomed Deutschland GmbH | Potsdam | |
| Germany | Nycomed Deutschland GmbH | Prien am Chiemsee | |
| Germany | Nycomed Deutschland GmbH | Radebeul | |
| Germany | Nycomed Deutschland GmbH | Rathenow | |
| Germany | Nycomed Deutschland GmbH | Recklinghausen | |
| Germany | Nycomed Deutschland GmbH | Regensburg | |
| Germany | Nycomed Deutschland GmbH | Regensburg | |
| Germany | Nycomed Deutschland GmbH | Rheda-Wiedenbrück | |
| Germany | Nycomed Deutschland GmbH | Rosenheim | |
| Germany | Nycomed Deutschland GmbH | Rostock | |
| Germany | Nycomed Deutschland GmbH | Sangerhausen | |
| Germany | Nycomed Deutschland GmbH | Schwedt | |
| Germany | Nycomed Deutschland GmbH | Schweinfurth | |
| Germany | Nycomed Deutschland GmbH | Singen | |
| Germany | Nycomed Deutschland GmbH | Solingen | |
| Germany | Nycomed Deutschland GmbH | Stuttgart | |
| Germany | Nycomed Deutschland GmbH | Traunstein | |
| Germany | Nycomed Deutschland GmbH | Trostberg | |
| Germany | Nycomed Deutschland GmbH | Ulm | |
| Germany | Nycomed Deutschland GmbH | Ulm | |
| Germany | Nycomed Deutschland GmbH | Weimar | |
| Germany | Nycomed Deutschland GmbH | Weißenfels | |
| Germany | Nycomed Deutschland GmbH | Wiesbaden | |
| Germany | Nycomed Deutschland GmbH | Wiesbaden | |
| Germany | Nycomed Deutschland GmbH | Wipperfurth | |
| Germany | Nycomed Deutschland GmbH | Wismar | |
| Germany | Nycomed Deutschland GmbH | Würzburg |
| Lead Sponsor | Collaborator |
|---|---|
| Nycomed |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales | Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless) | after surgery | Yes |
| Secondary | Pharmacoeconomic Benefits as Assessed by the Surgeon | Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no) | peri- and post-surgery until hospital discharge | No |
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