NCT00293514

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Nycomed · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Diseases
• Intraoperative Complications

Interventions

Type	Name	Description
DRUG	Fibrinogen (human) + thrombin (human) (TachoSil)

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-02-17
• Last updated: 2012-05-07

Locations

1 site across 1 country: Denmark