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

This study has been completed.
Sponsor:
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00700141
First received: June 17, 2008
Last updated: May 4, 2012
Last verified: April 2010
History of Changes
  Purpose

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.


Condition
Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)


Secondary Outcome Measures:
  • Pharmacoeconomic Benefits as Assessed by the Surgeon [ Time Frame: peri- and post-surgery until hospital discharge ] [ Designated as safety issue: No ]
    Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)


Enrollment: 482
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inpatients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700141

  Show 132 Study Locations
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00700141     History of Changes
Other Study ID Numbers: TC-031-DE
Study First Received: June 17, 2008
Results First Received: March 11, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Nycomed: A Takeda Company:
Tachosil
thyroid
parathyroid
 fleece-bound hemostasispathologic processes
hemorrhage
thyroid surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013