UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biocompatibility of a hemofilter coated with a polymer having a hydrophilic blood-contacting layer
Title of the study (Brief title)	Biocompatibility a hemofilter coated with a biocompatible polymer
Region	Japan

Condition
Condition	Cardiovascular and Thoracic Surgery Hemodialysis
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	If a biocompatible polymer coated hemofilter could be used, favorable effects could be expected in terms of anticoagulation of the extracorporeal circulation, not only in cardiopulmonary bypass surgeries but also in hemodialysis treatment. In this study, we aim to examine the anticoagulation effects of BPA-coated hemofilters
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Antithrombotic property in a polymer coated hemofilter (In-vitro)
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	No blood transfusion history, no current disease, no internal use within last 1 month
Key exclusion criteria	Hgb<13.5g/dL
Target sample size	20

Research contact person
Name of lead principal investigator	Masashi Tagaya
Organization	National Hospital Organization Kure Medical Center
Division name	Department of Medical Engineering
Address	3-1 Aoyamacho, Kure, Hiroshima 737-0023, Japan
TEL	0832-22-3111
Email	tagayam@kure-nh.go.jp

Public contact
Name of contact person	Masashi Tagaya
Organization	National Hospital Organization Kure Medical Center
Division name	Department of Medical Engineering
Address	3-1 Aoyamacho, Kure, Hiroshima 737-0023, Japan
TEL	0823-22-3111
Homepage URL
Email	tagayam@kure-nh.go.jp

Sponsor
Institute	National Hospital Organization Kure Medical Center
Institute
Department

Funding Source
Organization	Policy-Based Medical Services Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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	2018 Year 07 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 13 Day
Anticipated trial start date	2018 Year 02 Month 13 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	N/A

Management information
Registered date	2018 Year 07 Month 25 Day
Last modified on	2018 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038174