UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A validation study of hemostatic effect of SC-625A at anastomotic sites -Multicenter open-label randomized clinical study-
Title of the study (Brief title)	Hemostatic effect of the novel synthetic sealant (SC-625A) at anastomotic sites
Region	Japan

Condition
Condition	Thoracic aorta aneurism or dissection (without acute patients)
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Validation of safety and efficacy on hemostatic effect of SC-625A at anastomotic sites
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Hemorrhage (yes or no) at the site of vascular anastomosis immediately before and 15 minutes after protamine sulfate administration
Key secondary outcomes	Intraoperative transfusion volume and additional hemostatic procedures

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Test group: subjects who underwent thoracic aorta replacement surgery with the use of SC-625A during surgery
Interventions/Control_2	Control group: subjects who underwent thoracic aorta replacement surgery without the use of SC-625A during surgery (conventional therapy)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	82

Research contact person
Name of lead principal investigator	Masahiro Fukui
Organization	Sanyo Chemical Industries, Ltd.
Division name	Research & Development Division
Address	11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto, Japan
TEL	075-541-4311
Email	m.fukui@sanyo-chemical.com

Public contact
Name of contact person	Hiroaki Maeda
Organization	Sanyo Chemical Industries, Ltd.
Division name	Research & Development Division Bio & Medical Products Research Dept.
Address	11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto, Japan
TEL	075-541-6310
Homepage URL
Email	h.maeda@sanyo-chemical.com

Sponsor
Institute	Sanyo Chemical Industries, Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	九州大学大学病院（福岡県）、福岡大学病院（福岡県）、倉敷中央病院（岡山県）、国立循環器病センター（大阪府）、姫路循環器病センター（兵庫県）、九州医療センター（福岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 05 Month 26 Day
Anticipated trial start date	2006 Year 12 Month 06 Day
Last follow-up date	2009 Year 09 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.pmda.go.jp/PmdaSearch/
Results	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.
Other related information	None

Management information
Registered date	2016 Year 08 Month 19 Day
Last modified on	2016 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027274