| Exclusion Criteria: | 1) Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the previous 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.
2) Subjects with a known or suspected allergy to aprotinin.
3) Subjects undergoing laparoscopic surgery.
4) Subjects with sepsis.
5) Subjects with mesothelioma.
6) Subjects with a creatinine clearance less than 30 mL/min as calculated by Cockcroft-Gault formula. The Cockcroft-Gault formula to be used is: [(140-age) x (weight in kg) x 1.23 x (0.85 only if female)] / serum creatinine in micromoles/L.
7) Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
8) 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.
9) Subjects who refuse to receive allogenic blood products for religious or other reasons.
10) Subjects whose preoperative red blood cell volume is so low that a blood transfusion will have to be given perioperatively (pre-operative hematocrit or hemoglobin values <24% or < 8 g/dL, respectively).
11) Subjects with a history of deep vein thrombosis or pulmonary embolism.
12) Subjects who are pregnant or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception.
13) Use of other antifibrinolytic agents eg, aminocaproic acid (Amicar®) or tranexamic acid (Cyklokapron®)
14) Subjects on a chronic anti-coagulant treatment with warfarin where it can not be discontinued presurgery for the surgical procedure.
15) Subjects on an investigational drug (ie, not marketed) 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. |