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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023683
Receipt No. R000027274
Scientific Title A validation study of hemostatic effect of SC-625A at anastomotic sites -Multicenter open-label randomized clinical study-
Date of disclosure of the study information 2016/08/19
Last modified on 2016/08/19

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Basic information
Public title A validation study of hemostatic effect of SC-625A at anastomotic sites
-Multicenter open-label randomized clinical study-
Acronym Hemostatic effect of the novel synthetic sealant (SC-625A) at anastomotic sites
Scientific Title A validation study of hemostatic effect of SC-625A at anastomotic sites
-Multicenter open-label randomized clinical study-
Scientific Title:Acronym 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
1st name
Middle name
Last name Masahiro Fukui
Organization Sanyo Chemical Industries, Ltd.
Division name Research & Development Division
Zip code
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
1st name
Middle name
Last name Hiroaki Maeda
Organization Sanyo Chemical Industries, Ltd.
Division name Research & Development Division Bio & Medical Products Research Dept.
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.pmda.go.jp/PmdaSearch/
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 05 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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