HemorrhageNCT00700141

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

An observational study of Hemorrhage, run by Nycomed at 132 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemorrhage
How many people: 482 participants
Where: 132 sitesGermany
Study dates: Sep 2008to Jan 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Inpatients

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

Trial locations and contacts

132 sites in 1 country.

City, postcode or hospital

132 sites in 1 country

Germany132 sites

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

Other trials in Germany

About this study

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

Conditions: Hemorrhage
Keywords: Tachosil, thyroid, parathyroid, fleece-bound hemostasispathologic processes, hemorrhage, thyroid surgery
Medical subject headings: Hemorrhage, Thyroid Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: after surgery

Secondary outcomes (1)

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)
Measured: peri- and post-surgery until hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jan 2009

First posted18 Jun 2008 (estimated)
Study startSep 2008
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HemorrhageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 482 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00700141
Sponsor's protocol ID: TC-031-DE
Status last verified: Apr 2010
First submitted: 17 Jun 2008
Last updated: 8 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery
ClinicalTrials.gov ID: NCT00700141
Acronym / sponsor ID: TC-031-DE
Conditions: Hemorrhage
Keywords: Tachosil, thyroid, parathyroid, fleece-bound hemostasispathologic processes, hemorrhage, thyroid surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 482 participants (actual)
Lead sponsor: NycomedIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 18 Jun 2008 (estimated)
Results: Posted 6 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Inpatients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)

1 secondary outcome

Pharmacoeconomic Benefits as Assessed by the Surgeon
Time frame: peri- and post-surgery until hospital discharge

Results and safety

Results posted to the registry on 6 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TachoSil® Application	482	482

Primary outcome: 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. Mean (Standard Deviation). Unit: Units on a scale

Measure	TachoSil® Application n = 481
Handling	2.54 (1.52)
Satisfaction	2.25 (1.80)
Utility	2.42 (1.63)

Population analysed: All 482 patients included and treated with TachoSil® \[= Intention to Treat population (ITT)\], missing values not imputed. For one patient missing information in all three scales (Handling, Utility and Satisfaction in the Operation)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: peri- and post-surgery until hospital discharge. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TachoSil® Application	0 of 482 (0%)	0 of 482 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemorrhage

Recruiting
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Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Thomas D. Bethke, MD, MBA study director

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

132 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhage, run by Nycomed at 132 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00700141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.