None listed
Conditions
Brief summary
This trial is a randomized, double-blind (investigator and patient), multi-center, 2 arm, parallel design study of aprotinin (Trasylol) versus placebo in subjects undergoing selected surgeries on the lung consisting of planned complete primary pneumonectomy or other pulmonary resection with high likelihood of blood transfusion, completion pneumonectomy or decortication for lung cancer, or undergoing esophagectomy (by transthoracic or transhiatal approach) for esophageal cancer. The aprotinin or placebo will be given by intravenous infusion until the end of the surgery.
Interventions
This trial is a randomized, double-blind, multi-center, 2 arm, parallel design study of aprotinin (Trasylol) versus placebo in subjects undergoing selected surgeries on the lung consisting of planned complete primary pneumonectomy or other pulmonary resection with high likelihood of blood transfusion, completion pneumonectomy or decortication for lung cancer, or undergoing esophagectomy (by transthoracic or transhiatal approach) for esophageal cancer. Prior to skin incision 2 million kallikre
This trial is a randomized, double-blind, multi-center, 2 arm, parallel design study of aprotinin (Trasylol) versus placebo in subjects undergoing selected surgeries on the lung consisting of planned complete primary pneumonectomy or other pulmonary resection with high likelihood of blood transfusion, completion pneumonectomy or decortication for lung cancer, or undergoing esophagectomy (by transthoracic or transhiatal approach) for esophageal cancer. Prior to skin incision 2 million kallikrein-inhibiting units (KIU) of aprotin will be given by intravenous infusion, followed by 500,000 KIU/hour until the of surgery.
Sponsors
Bayer Australia Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects requiring protocol specified oncological surgery. Subjects must have histological or cytological confirmation of malignancy in lung or esophagus.Documented, signed, dated informed consent obtained prior to any study specific procedures being performed.
Exclusion criteria
Subjects with previous exposure to aprotinin in the last 6 months. Subjects with a known or suspected allergy to aprotinin.Subjects undergoing laparoscopic surgery resection.Subjects undergoing thoracoscopic resection or simple lobectomy as the planned procedure.Subjects undergoing any palliative operation.Subjects with sepsis.Subjects with mesothelioma.Subjects with impaired renal function.Subjects with a history of bleeding diathesis or known coagulation factor deficiency. Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject’s ability to complete the study or precludes the subject’s participation in the study.Subjects who refuse to receive allogenic blood products for religious or other reasons.Subjects whose preoperative red blood cell volume is so low that a blood transfusion will have to be given perioperatively.Subjects with a history of deep vein thrombosis or pulmonary embolism.Subjects who are pregnant or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening and who are not using a reliable method of contraception.Women of childbearing potential who are not using a reliable method of contraception. Use of other antifibrinolytic agents.Subjects on a chronic anti-coagulant treatment with warfarin vitamin K antagonists where it can not be discontinued presurgery for the surgical procedure.Subjects on an investigational drug in the 30 days prior to screening or during the trial before the 6 week follow-up visit. Subjects involved in trials of marketed cancer therapy medications (including those approved for another indication) or combination with radiotherapy are allowed. Subjects with known drug hypersensitivity, subjects with an allergic diathesis, and subjects who have been treated with aprotinin more than 6 month ago. For subjects for whom there is a suspicion of previous treatment with aprotinin, they may be included in the study only if precautions as outlined in the protocol are undertaken.
Outcome results
None listed