An open, randomised, prospective, multi-centre, parallel-group trial to compare efficacy and safety of TachoSil versus standard surgical treatment in patients undergoing pulmonary lobectomy for lung malignancy and requiring treatment for air leakage - TachoSil versus standard surgical treatment for air leakage in pulmonary lobectomy

• Conditions: Management of pulmonary air leakage following lobectomy in subjects with lung malignancies including metastases.; Level: PTClassification code 10024741

• Registration Number: EUCTR2004-002380-24-IT
• Lead Sponsor: YCOMED HEADQUARTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Pre-operative Informed consent obtained, 18 years of age or above, planned elective lobectomy for lung malingnancy with intrapulmonary lymphadenectomy with antero- or postero-lateral incision , use of adequate contraception for females. After pulmonary lobectomy Air leakage of grade 1 or 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pre-operative Previous lung surgery; anti-tumour chemotherapy within last 3 weeks; radiotherapy for lung malingnancy within last 4 weeks; allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin; emergency surgery, FEV1 forced expiratory volume 40 ; previousely exposure to TachoComb, TachoComb H or TachoSil; present abuse of drug or alcohol, participation in any other trial with an investigational drug or device within 30 days prior to inclusion, participation or planned praticipation in another trial during the trial period; positive pregnancy test females and breastfeeding females . After pulmonary lobectomy Serious complications including need for surgical adhesiolysis of the remaining lung tissue, pneumonectomy, additional wedge resection of the lung, use of any fibrin sealant including TachoSil before randomisation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified