UMIN-CTR Clinical Trial

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

Thoracic aorta aneurism or dissection (without acute patients)

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Sanyo Chemical Industries, Ltd.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

08

Month

19

Day

URL releasing protocol

Publication of results

Published

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

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 related information

None

Registered date

2016

Year

08

Month

19

Day

Last modified on

2016

Year

08

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027274