UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A random-control study of PMMA membrane as a filtrating agent of ascites in cell-free and concentrated ascites rein fusion therapy (CART) against patients with refractory ascites
Title of the study (Brief title)	A random-control study of CART using PMMA membrane against patients with refractory ascites
Region	Japan

Condition
Condition	refractory ascites
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the usefulness of PMMA membrane as a filtration agent in CART against patients against refractory ascites
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	fever up within 24 hours after CART
Key secondary outcomes	duration of next CART session

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Polystyrene(PS) membrane group Use polystyrene membrane when concentrating ascites before performing CART. Use day 1 only.
Interventions/Control_2	polymethylmethacrylate(PMMA) membrane group Use polymethylmethacrylate membrane when concentrating ascites before performing CART. Use day 1 only.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Liver cirrhosis patients with refractory ascites of age 20 years or older (without gender) 2) Regarding participation in this study, please give sufficient explanation to yourself before starting the exam and consent by the document by the person The obtained patient 3) Patients who are expected to survive for 4 weeks or more 4) Patients meeting the following clinical testing criteria a) Hemoglobin: > 8.0 g / dl b) Neutrophils: > 1500 / mm3 c) Platelets: > 30000 / mm3 d) Total bilirubin: <4.0 mg / dL e) ALT and AST: < 6 times facility standard f) Serum creatinine: < 2.0 g) Serum sodium concentration: > 120 mEq / L
Key exclusion criteria	1) Patients with heart disease corresponding to the following a) Patients with NYHA class 3 or higher congestive heart failure b) Patients with poorly controlled hypertension 2) Patients with severe and active infections (excluding HBV and HCV) 3) Patients with history of HIV infection 4) Patients during hemodialysis 5) Patients with portal vein tumor plugs with Vp3 or more 6) Patients with hepatic encephalopathy who are difficult to properly hydrate 7) Patients who had gastrointestinal bleeding which clinically becomes problem within 4 weeks before the start of the study 8) Patients who received treatment corresponding to the following a) Systemic chemotherapy b) Invasive surgery within 4 weeks before the start of the study 9) Pregnant women Patients who have a possibility or intent during lactation and pregnancy 10) Patients who may have an allergic reaction to this test device 11) Health condition, psychological state, social situation that interferes with substance abuse, participation in this study and evaluation of results Patient involved 12) In addition, if there is a possibility of impairing patient safety in conducting this examination, or When it is judged that compliance is difficult
Target sample size	20

Research contact person
Name of lead principal investigator	Mitsuteru Kitade
Organization	Nara Medical University
Division name	Third Department of Internal Medicine
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744223051
Email	kitadem@naramed-u.ac.jp

Public contact
Name of contact person	Mitsuteru Kitade
Organization	Nara Medical University
Division name	Third Department of Internal Medicine
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744223051
Homepage URL
Email	kitadem@naramed-u.ac.jp

Sponsor
Institute	Third Department of Internal Medicine, Nara Medical University
Institute
Department

Funding Source
Organization	Third Department of Internal Medicine, Nara Medical University
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	2018 Year 02 Month 21 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 01 Day
Anticipated trial start date	2015 Year 01 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

Management information
Registered date	2018 Year 02 Month 20 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035506