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
Phase 3
18 Years
90 Years
18 Years
90 Years
Not Enrolling
Both
Pulmonary Diseases, Intraoperative Complications
Both
Pulmonary Diseases, Intraoperative Complications
Trial Information
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
Inclusion Criteria:
- Subjects with a diagnosis of lung malignancy with or without metastases may be
included in the trial if the entry criteria apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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)
Principal Investigator
Nycomed Clinical Trial Operations
Investigator Role:
Study Chair
Investigator Affiliation:
Headquarters
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
TC-021-IM
NCT ID:
NCT00293514
Start Date:
February 2006
Completion Date:
October 2007
Related Keywords:
- Pulmonary Diseases
- Intraoperative Complications
- standard surgical treatment for air leakage in pulmonary lobectomy
- Intraoperative Complications
- Lung Diseases
- Respiration Disorders
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