UMIN-CTR Clinical Trial

Basic information
Public title	Use-results survey of Matsudaito
Acronym	Post marketing surveillance of Hydrofit
Scientific Title	Prospective registry study of efficacy and safety on post marketing surveillance of Matsudaito for hemostasis of vascular anastomosis
Scientific Title:Acronym	Prospective registry study on post marketing surveillance of Hydrofit
Region	Japan

Condition
Condition	Thoracic aorta aneurism or dissection
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the efficacy and safety in the actual clinical use, based on the results of this surveillance
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of defects and adverse events during 1 year follow-up
Key secondary outcomes	Hemostatic effect during surgical procedure, and presence/absence of additional hemostatic procedures

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Hemostasis with Hydrofit
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Patients treated with Hydrofit to stop bleeding 2 Patient registered on use-result survey of Hydrofit
Key exclusion criteria	not determined
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name Amano
Organization	Sanyo Chemical Industries, Ltd.
Division name	Biotechnology & Medical Division
Zip code	605-0995
Address	11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto, Japan
TEL	075-541-6318
Email	y.amano@sanyo-chemical.group

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Maeda
Organization	Sanyo Chemical Industries, Ltd.
Division name	Biotechnology & Medical Division Regulatory Affairs dept.
Zip code	605-0995
Address	11-1, Ikkyo Nomoto-cho, Higashiyama-ku, Kyoto, Japan
TEL	075-541-6310
Homepage URL
Email	h.maeda@sanyo-chemical.group

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	N/A
Address	N/A
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

北海道大野記念病院、北海道大学病院、札幌心臓血管クリニック、岩手医科大学附属病院、東北大学病院、自治医科大学附属病院、群馬県立心臓血管センター、伊勢崎市民病院、埼玉石心会病院、春日部中央総合病院、上尾中央総合病院、榊原記念病院、東京医科大学病院、イムス葛飾ハートセンター、聖路加国際病院、帝京大学医学部附属病院、石心会 川崎幸病院、横浜市立大学附属市民総合医療センター、東海大学医学部附属病院、立川綜合病院、佐久総合病院、国立病院機構名古屋大学医学部附属病院、名古屋徳洲会総合病院、佐久医療センター、静岡医療センター、藤田医科大学病院、名古屋第二赤十字病院、安城更生病院、一宮市立市民病院、三重大学医学部、京都府立医科大学、京都第一赤十字病院、舞鶴共済病院附属病院附属病院、国立循環器病 兵庫県立明石医療センター、神戸大学医学部附属病院研究センター、姫路循環器病センター、神戸市立医療センター中央市民病院、天理よろづ相談所病院、和歌山県立医科大学附属病院、鳥取大学医学部附属病院「憩の家」、倉敷中央病院、九州大学病院、福岡大学病院、国立病院機構、心臓病センター、九州医療センター、済生会熊本病院、大分大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 22 Day

Related information
URL releasing protocol	http://www.pmda.go.jp/PmdaSearch/
Publication of results	Published

Result
URL related to results and publications	https://www.pmda.go.jp/PmdaSearch/kikiSearch/
Number of participants that the trial has enrolled	576
Results	<Efficacy verification> 95.6% of anastomotic sites showed hemostatic effect, and 66.7% of anastomotic sites didn't need additional hemostatic procedure, suggesting excellent hemostatic effect. <Safety verification> 94 patients defects/adverse events (incidence rate:16.3%) were reported. Without specificity on the types and occurrence/severity of the AEs, no AEs considered specific to the product. <Summary> Hydrofit is effective and safe, with no problems with the safety and efficacy in real use.
Results date posted	2021 Year 04 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients who underwent thoracic aorta replacement surgery
Participant flow	Patients treated with Hydrofit
Adverse events	General adverse events which are commonly observed after aortic replacement surgery
Outcome measures	Safety and efficacy
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 02 Day
Date of IRB	2013 Year 12 Month 10 Day
Anticipated trial start date	2014 Year 06 Month 12 Day
Last follow-up date	2017 Year 03 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 22 Day
Last modified on	2022 Year 04 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050041