1) Patients having severe hepatic disorder (patients having any of following criteria).
Total bilirubin level is higher than 2.3 mg/dL.
AST level is higher than 3.0x the upper limit of normal range of the institution.
ALT level is higher than 3.0x the upper limit of normal range in the institution.
2) Patient having severe renal disorder (patients having any of following criteria).
BUN level is higher than 40 mg/dL.
Creatinine level is higher than 40 mg/dL. |
| 3) Patients having severe heart failure (Patients with NYHA classification IV3). |
| 4) Pregnant patients or possibly pregnant patients (Patients who are diagnosed as positive in pregnancy test [except for pregnant or post-menopausal patients]) |
| 5) Patients who are infected with hepatitis B, hepatitis C or syphilis |
| 6) Patients who underwent blood collection (blood donation) of more than 200 ml with a month, or of more than 400 ml within 3 months counted from the scheduled operation date (except for collection for autologous blood transfusion) |
| 7) Patients who participated in other clinical trials within 6 months counted from the scheduled operating date |
| 8) Patient who underwent craniotomy within a month counted from the scheduled operation date |
| 9) Patients who are judged not to be eligible by principal and sub investigators because of expected difficulty in compliance of protocol etc. |
