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

Nycomed

Status and phase: Completed; Phase 3

Conditions: Pulmonary Diseases; Intraoperative Complications

Treatments: Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293514

TC-021-IM

2004-002380-24

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)