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

This study has been completed.
Information provided by:
Nycomed Identifier:
First received: February 15, 2006
Last updated: May 4, 2012
Last verified: February 2008
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
Intervention Model: Parallel Assignment
Masking: None (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:

Further study details as provided by Nycomed:

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)

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00293514

Roskilde, Denmark, 4000
Sponsors and Collaborators
Study Chair: Nycomed Clinical Trial Operations Headquarters
  More Information

Responsible Party: Nycomed, Clinical Trial Operations Identifier: NCT00293514     History of Changes
Other Study ID Numbers: TC-021-IM
Study First Received: February 15, 2006
Last Updated: May 4, 2012

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

Additional relevant MeSH terms:
Lung Diseases
Intraoperative Complications
Respiratory Tract Diseases
Pathologic Processes
Coagulants processed this record on September 21, 2017