Back to resultsTachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
Primary Purpose
Pulmonary Diseases, Intraoperative Complications
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Fibrinogen (human) + thrombin (human) (TachoSil)
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Diseases focused on measuring standard surgical treatment for air leakage in pulmonary lobectomy
Eligibility 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.
Sites / Locations
- Nycomed
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00293514
Brief Title
TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nycomed
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Diseases, Intraoperative Complications
Keywords
standard surgical treatment for air leakage in pulmonary lobectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fibrinogen (human) + thrombin (human) (TachoSil)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Reduction of intra-operative air leakage intensity after first application of trial treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nycomed Clinical Trial Operations
Organizational Affiliation
Headquarters
Official's Role
Study Chair
Facility Information:
Facility Name
Nycomed
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
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