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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293514
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : May 7, 2012
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Diseases Intraoperative Complications Drug: Fibrinogen (human) + thrombin (human) (TachoSil) Phase 3

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : February 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Reduction of intra-operative air leakage intensity after first application of trial treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293514

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

Responsible Party: Nycomed, Clinical Trial Operations Identifier: NCT00293514     History of Changes
Other Study ID Numbers: TC-021-IM
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: February 2008

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