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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
ClinicalTrials.gov Identifier:
NCT00700141
First received: June 17, 2008
Last updated: May 4, 2012
Last verified: April 2010
  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:


Further study details as provided by Nycomed:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 132 Study Locations
Sponsors and Collaborators
Nycomed
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:
Tachosil
thyroid
parathyroid
fleece-bound hemostasispathologic processes
hemorrhage
thyroid surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014