A validation study of hemostatic effect of SC-625A at anastomotic sites -Multicenter open-label randomized clinical study

Phase 3

• Conditions: Thoracic aorta aneurism or dissection (without acute patients)

• Registration Number: JPRN-UMIN000023683
• Lead Sponsor: Sanyo Chemical Industries, Ltd.

Brief Summary

Efficacy Primary endpoints: The hemostatic rate immediately before protamine sulfate administration was 79.1% in the SC-625A group and 38.5% in the control group. The hemostatic rate 15 minutes after protamine sulfate administration was 88.3% in the SC-625A group and 60.7% in the control group. The SC-625A group showed a significant difference in the hemostatic rate at each point compared to the control group (p < 0.001, Fisher's exact test). Secondary endpoints: There was a significant difference in the percentage of additional hemostatic procedures performed after protamine sulfate administration between the 2 groups: 19.4% anastomoses in the SC-625A group and 55.6% anastomoses in the control group (p < 0.001, Fisher's exact test) required an additional hemostatic procedure. There was a slight, but not significant, difference (p = 0.057) in the transfusion volume of frozen plasma between subjects in the control and SC-625A groups. Safety There was no additional risk attributable to the use of SC-625A in subjects who underwent thoracic aorta replacement surgery compared to subjects who underwent thoracic aorta replacement without the use of SC-625A.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-09-25
• Study Start: 2016-08-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemorrhage (yes or no) at the site of vascular anastomosis immediately before and 15 minutes after protamine sulfate administration

Secondary Outcome Measures

Name	Time	Method
Intraoperative transfusion volume and additional hemostatic procedures