Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®

May 4, 2012 updated by: Nycomed

Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery

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.

Study Overview

Status

Completed

Conditions

Hemorrhage

Study Type

Observational

Enrollment (Actual)

482

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Aschaffenburg, Germany, 63739
    - Nycomed Deutschland GmbH
  - Aschersleben, Germany, 06449
    - Nycomed Deutschland GmbH
  - Bad Berka, Germany, 99437
    - Nycomed Deutschland GmbH
  - Bad Salzungen, Germany, 36433
    - Nycomed Deutschland GmbH
  - Bad Tölz, Germany, 83646
    - Nycomed Deutschland GmbH
  - Baden-Baden, Germany, 76532
    - Nycomed Deutschland GmbH
  - Bayreuth, Germany, 95445
    - Nycomed Deutschland GmbH
  - Berlin, Germany, 10117
    - Nycomed Deutschland GmbH
  - Berlin, Germany, 12559
    - Nycomed Deutschland GmbH
  - Berlin, Germany, 14193
    - Nycomed Deutschland GmbH
  - Berlin, Germany, 10365
    - Nycomed Deutschland GmbH
  - Berlin, Germany, 12157
    - Nycomed Deutschland GmbH
  - Bielefeld, Germany, 33604
    - Nycomed Deutschland GmbH
  - Bielefeld, Germany, 33611
    - Nycomed Deutschland GmbH
  - Bischofswerda, Germany, 01877
    - Nycomed Deutschland GmbH
  - Bochum, Germany, 44791
    - Nycomed Deutschland GmbH
  - Bonn, Germany, 53115
    - Nycomed Deutschland GmbH
  - Bottrop, Germany, 46242
    - Nycomed Deutschland GmbH
  - Braunschweig, Germany, 38124
    - Nycomed Deutschland GmbH
  - Bruchsal, Germany, 76646
    - Nycomed Deutschland GmbH
  - Chemnitz, Germany, 09116
    - Nycomed Deutschland GmbH
  - Coswig, Germany, 01640
    - Nycomed Deutschland GmbH
  - Cottbus, Germany, 03048
    - Nycomed Deutschland GmbH
  - Deggendorf, Germany, 94469
    - Nycomed Deutschland GmbH
  - Detmold, Germany, 32756
    - Nycomed Deutschland GmbH
  - Dinkelsbühl, Germany, 91550
    - Nycomed Deutschland GmbH
  - Dortmund, Germany, 44137
    - Nycomed Deutschland GmbH
  - Duisburg, Germany, 47001
    - Nycomed Deutschland GmbH
  - Düsseldorf, Germany, 40489
    - Nycomed Deutschland GmbH
  - Düsseldorf, Germany, 40225
    - Nycomed Deutschland GmbH
  - Düsseldorf, Germany, 40549
    - Nycomed Deutschland GmbH
  - Eberswalde, Germany, 16225
    - Nycomed Deutschland GmbH
  - Eckernförde, Germany, 24340
    - Nycomed Deutschland GmbH
  - Eichsfeld, Germany, 37355
    - Nycomed Deutschland GmbH
  - Eisenach, Germany, 99817
    - Nycomed Deutschland GmbH
  - Erfurt, Germany, 99097
    - Nycomed Deutschland GmbH
  - Erlangen, Germany, 91054
    - Nycomed Deutschland GmbH
  - Essen, Germany, 45329
    - Nycomed Deutschland GmbH
  - Essen, Germany, 45136
    - Nycomed Deutschland GmbH
  - Frankfurt, Germany, 60318
    - Nycomed Deutschland GmbH
  - Frankfurt (Oder), Germany, 15236
    - Nycomed Deutschland GmbH
  - Frechen, Germany, 50226
    - Nycomed Deutschland GmbH
  - Freudenstadt, Germany, 72233
    - Nycomed Deutschland GmbH
  - Fürstenfeldbruck, Germany, 82256
    - Nycomed Deutschland GmbH
  - Fürth, Germany, 90766
    - Nycomed Deutschland GmbH
  - Gelnhausen, Germany, 63571
    - Nycomed Deutschland GmbH
  - Gelsenkirchen, Germany, 45894
    - Nycomed Deutschland GmbH
  - Gera, Germany, 07548
    - Nycomed Deutschland GmbH
  - Gummersbach, Germany, 51643
    - Nycomed Deutschland GmbH
  - Göppingen, Germany, 73035
    - Nycomed Deutschland GmbH
  - Görlitz, Germany, 02828
    - Nycomed Deutschland GmbH
  - Hagen, Germany, 58097
    - Nycomed Deutschland GmbH
  - Halle, Germany, 06120
    - Nycomed Deutschland GmbH
  - Hamburg, Germany, 20099
    - Nycomed Deutschland GmbH
  - Hamburg, Germany, 22043
    - Nycomed Deutschland GmbH
  - Hamburg, Germany, 22087
    - Nycomed Deutschland GmbH
  - Hamburg, Germany, 22359
    - Nycomed Deutschland GmbH
  - Hamburg, Germany, 22417
    - Nycomed Deutschland GmbH
  - Hamm, Germany, 59073
    - Nycomed Deutschland GmbH
  - Hanau, Germany, 63450
    - Nycomed Deutschland GmbH
  - Hartmannsdorf, Germany, 09232
    - Nycomed Deutschland GmbH
  - Hausham, Germany, 83734
    - Nycomed Deutschland GmbH
  - Heilbronn, Germany, 74064
    - Nycomed Deutschland GmbH
  - Heinsberg, Germany, 52525
    - Nycomed Deutschland GmbH
  - Herten, Germany, 45697
    - Nycomed Deutschland GmbH
  - Ibbenbüren, Germany, 49477
    - Nycomed Deutschland GmbH
  - Ingolstadt, Germany, 85049
    - Nycomed Deutschland GmbH
  - Jena, Germany, 07747
    - Nycomed Deutschland GmbH
  - Karlsruhe, Germany, 76137
    - Nycomed Deutschland GmbH
  - Karlsruhe, Germany, 76199
    - Nycomed Deutschland GmbH
  - Kassel, Germany, 34121
    - Nycomed Deutschland GmbH
  - Kassel, Germany, 34127
    - Nycomed Deutschland GmbH
  - Konstanz, Germany, 78464
    - Nycomed Deutschland GmbH
  - Köln, Germany, 50733
    - Nycomed Deutschland GmbH
  - Köln-Lindenthal, Germany, 50931
    - Nycomed Deutschland GmbH
  - Langen, Germany, 63225
    - Nycomed Deutschland GmbH
  - Leipzig, Germany, 04129
    - Nycomed Deutschland GmbH
  - Leipzig, Germany, 04289
    - Nycomed Deutschland GmbH
  - Lichtenfels, Germany, 96215
    - Nycomed Deutschland GmbH
  - Lohr am Main, Germany, 97816
    - Nycomed Deutschland GmbH
  - Luckenwalde, Germany, 14943
    - Nycomed Deutschland GmbH
  - Lörrach, Germany, 79539
    - Nycomed Deutschland GmbH
  - Lübbecke, Germany, 32312
    - Nycomed Deutschland GmbH
  - Lübeck, Germany, 23560
    - Nycomed Deutschland GmbH
  - Magdeburg, Germany, 39130
    - Nycomed Deutschland GmbH
  - Mainz, Germany, 55131
    - Nycomed Deutschland GmbH
  - Mainz, Germany, 55101
    - Nycomed Deutschland GmbH
  - Mannheim, Germany, 68167
    - Nycomed Deutschland GmbH
  - Mannheim, Germany, 68163
    - Nycomed Deutschland GmbH
  - Marburg, Germany, 35033
    - Nycomed Deutschland GmbH
  - Meppen, Germany, 49716
    - Nycomed Deutschland GmbH
  - Mettmann, Germany, 40822
    - Nycomed Deutschland GmbH
  - München, Germany, 80638
    - Nycomed Deutschland GmbH
  - Münster, Germany, 48143
    - Nycomed Deutschland GmbH
  - Münster, Germany, 48153
    - Nycomed Deutschland GmbH
  - Neu-Ulm, Germany, 89231
    - Nycomed Deutschland GmbH
  - Neumarkt in der Oberpfalz, Germany, 92318
    - Nycomed Deutschland GmbH
  - Neumünster, Germany, 24535
    - Nycomed Deutschland GmbH
  - Neuruppin, Germany, 16816
    - Nycomed Deutschland GmbH
  - Nordhausen, Germany, 99734
    - Nycomed Deutschland GmbH
  - Nürnberg, Germany, 90491
    - Nycomed Deutschland GmbH
  - Oberhausen, Germany, 46145
    - Nycomed Deutschland GmbH
  - Oldenburg, Germany, 26133
    - Nycomed Deutschland GmbH
  - Oldenburg, Germany, 26121
    - Nycomed Deutschland GmbH
  - Pforzheim, Germany, 75175
    - Nycomed Deutschland GmbH
  - Potsdam, Germany, 14467
    - Nycomed Deutschland GmbH
  - Prien am Chiemsee, Germany, 83209
    - Nycomed Deutschland GmbH
  - Radebeul, Germany, 01554
    - Nycomed Deutschland GmbH
  - Rathenow, Germany, 14712
    - Nycomed Deutschland GmbH
  - Recklinghausen, Germany, 45657
    - Nycomed Deutschland GmbH
  - Regensburg, Germany, 93042
    - Nycomed Deutschland GmbH
  - Regensburg, Germany, 93053
    - Nycomed Deutschland GmbH
  - Rheda-Wiedenbrück, Germany, 33378
    - Nycomed Deutschland GmbH
  - Rosenheim, Germany, 83022
    - Nycomed Deutschland GmbH
  - Rostock, Germany, 18055
    - Nycomed Deutschland GmbH
  - Sangerhausen, Germany, 06526
    - Nycomed Deutschland GmbH
  - Schwedt, Germany, 16303
    - Nycomed Deutschland GmbH
  - Schweinfurth, Germany, 97421
    - Nycomed Deutschland GmbH
  - Singen, Germany, 78221
    - Nycomed Deutschland GmbH
  - Solingen, Germany, 42653
    - Nycomed Deutschland GmbH
  - Stuttgart, Germany, 70199
    - Nycomed Deutschland GmbH
  - Traunstein, Germany, 83278
    - Nycomed Deutschland GmbH
  - Trostberg, Germany, 83308
    - Nycomed Deutschland GmbH
  - Ulm, Germany, 89073
    - Nycomed Deutschland GmbH
  - Ulm, Germany, 89081
    - Nycomed Deutschland GmbH
  - Weimar, Germany, 99425
    - Nycomed Deutschland GmbH
  - Weißenfels, Germany, 06667
    - Nycomed Deutschland GmbH
  - Wiesbaden, Germany, 65189
    - Nycomed Deutschland GmbH
  - Wiesbaden, Germany, 65199
    - Nycomed Deutschland GmbH
  - Wipperfurth, Germany, 51688
    - Nycomed Deutschland GmbH
  - Wismar, Germany, 23966
    - Nycomed Deutschland GmbH
  - Würzburg, Germany, 97080
    - Nycomed Deutschland GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales Time Frame: after surgery	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacoeconomic Benefits as Assessed by the Surgeon Time Frame: peri- and post-surgery until hospital discharge	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nycomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria