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TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)

This study has been completed.
Sponsor:
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00293514
First received: February 15, 2006
Last updated: May 4, 2012
Last verified: February 2008
History of Changes
  Purpose

The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.


Condition Intervention Phase
Pulmonary Diseases
Intraoperative Complications
 Drug: Fibrinogen (human) + thrombin (human) (TachoSil)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatment for Air Leakage

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts)

Secondary Outcome Measures:
  • Reduction of intra-operative air leakage intensity after first application of trial treatment

Study Start Date: February 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293514

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

No publications provided

Responsible Party: Nycomed, Clinical Trial Operations
ClinicalTrials.gov Identifier: NCT00293514     History of Changes
Other Study ID Numbers: TC-021-IM, 2004-002380-24
Study First Received: February 15, 2006
Last Updated: May 4, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Ministry of Social Affairs, Public Health and the Environment
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic

Keywords provided by Nycomed: A Takeda Company:
standard surgical treatment for air leakage in pulmonary lobectomy

Additional relevant MeSH terms:
Intraoperative Complications
Lung Diseases
Respiration Disorders
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013