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 malingnancy and requiring treatment for air leakage. - TachoSil versus standard surgical treatment for air leakage in pulmonary lobectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002380-24-AT

Enrollment

300

Registered

2005-11-24

Start date

2005-12-29

Completion date

Unknown

Last updated

2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of pulmonary air leakage following lobectomy in subjects with lung malignancies including metastases. MedDRA version: 8.1 Level: PT Classification code 10024741

Interventions

Trade Name: TachoSil Product Name: TachoSil Pharmaceutical Form: Other descriptive name: human fibrinogen Concentration number: 5.5 mg per cm2- Other descriptive name: human thrombin Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare sealing efficacy and safety of TachoSil versus standard surgical treatment as secondary management of intra-operative pulmonary air leakage after lobectomy in subjects with lung malignancies including metastases. ;Secondary Objective: ;Primary end point(s): Duration of post-operative air leakage.	—

Countries

Austria, Belgium, Denmark, Germany, Hungary, Italy, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026