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

This study has been completed.

First Received: February 15, 2006 Last Updated: February 26, 2008 History of Changes

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00293514

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 III

MedlinePlus related topics: Cancer Surgery

Drug Information available for: TachoSil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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)

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

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquarters

More Information

No publications provided

Responsible Party:	Clinical Trial Operations ( Nycomed )
Study ID Numbers:	TC-021-IM, 2004-002380-24
Study First Received:	February 15, 2006
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00293514 History of Changes
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:

standard surgical treatment for air leakage in pulmonary lobectomy

Study placed in the following topic categories:

Thrombin
Respiratory Tract Diseases
Lung Diseases
Intraoperative Complications

Additional relevant MeSH terms:

Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Intraoperative Complications

ClinicalTrials.gov processed this record on May 07, 2009