UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Blood coagulation function test of adspray gel
Title of the study (Brief title)	Blood coagulation function test of adspray gel
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Blood coagulation function (thrombosis, coagulation and platelets) of adspray gel is confirmed by using human fresh blood.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Macroscopic observation of Thrombus attachment 2)beta-TG 3)TAT 4)Platelet count
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)not a carrier of HB antigen 2)no anemia 3)Confirming no problem with blood supply in medical checkup by doctor.
Key exclusion criteria	no regulation
Target sample size	5

Research contact person
Name of lead principal investigator	Hirohisa Kobayashi
Organization	Terumo Corporation
Division name	Evaluation Center
Address	1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL	0465-81-4142
Email	Hirohisa_Kobayashi@terumo.co.jp

Public contact
Name of contact person	Hirokazu Hasegawa
Organization	Terumo Corporation
Division name	R&D Administration and Promotion Department
Address	1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL	0465-81-4115
Homepage URL
Email	Hirokazu_Hasegawa@terumo.co.jp

Sponsor
Institute	Terumo Corporation
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In this study, blood coagulation function of the adspray gel is confirmed by comparing the group of only human fresh blood with the group of human fresh blood added to adspray gel.

Management information
Registered date	2017 Year 08 Month 01 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032584