Thoracic aorta aneurism or dissection (without acute patients)
Conditions
Interventions
Test group: subjects who underwent thoracic aorta replacement surgery with the use of SC-625A during surgery
Control group: subjects who underwent thoracic aorta replacement surgery without the use of
Sponsors
Sanyo Chemical Industries, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients undergoing thoracic aorta replacement 2)Patients aged >=20 and <80 years 3)Patients who understood the purpose of the study and gave written informed consent
Exclusion criteria
Exclusion criteria: 1)Ruptured aneurysm 2)Acute dissection 3)Reoperation (reoperation performed using the same incision site) 4)Patients with a serious infection that may affect evaluation for the study, in the opinion of the study investigator or sub-investigator 5)Patients with severe anemia who were judged ineligible for the study by the study investigator or sub-investigator (hemoglobin level: <9.0 g/dL) 6)Patients with serious complications involving the liver, kidney, or lung The seriousness was judged based on the following criteria: Total bilirubin level, >3.0 mg/dL;creatinine, >2.0 mg/dL;forced expiratory volume in 1 second, <1.0 L, PaO2 (room air), <60 mmHg,or SpO2 (room air), <90% 7)Patients with existing coagulation or fibrinolytic system abnormalities before the surgery, for whom continuous treatment of the condition was necessary postoperatively (FDP, >30 ug/mL [or FDP-E, >210 ng/mL], or platelet count, <100,000/mm3) 7)Patients with existing coagulation or fibrinolytic system abnormalities before the surgery, for whom continuous treatment of the condition was necessary postoperatively (FDP, >30 ug/mL [or FDP-E, >210 ng/mL], or platelet count, <100,000/mm3) 8)Patients taking oral corticosteroids 9)Patients with diabetes mellitus whose glucose control was judged to be inadequate (Hb A1c> 8.0%) 10)Patients with a cerebrovascular or neurological disorder who were judged ineligible for the study by the study investigator or sub-investigator 11)Pregnant women 12)Patients undergoing aortic root replacement (Bentall operation, valve-sparing aortic root replacement) 13)Patients participating in other clinical trials 14)Other patients who were judged ineligible by the study investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemorrhage (yes or no) at the site of vascular anastomosis immediately before and 15 minutes after protamine sulfate administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative transfusion volume and additional hemostatic procedures | — |
Countries
Japan
Contacts
Public ContactHiroaki Maeda
Sanyo Chemical Industries, Ltd. Research & Development Division Bio & Medical Products Research Dept.
Outcome results
None listed