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

ycomed Danmark ApS, International Medical Affairs0 个研究点目标入组 300 人开始时间: 2006年1月2日最近更新: 2021年8月2日

适应症

试验速览

暂无简介。

•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

•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.

发起方

ycomed Danmark ApS, International Medical Affairs