UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031393
Receipt No. R000035506
Scientific Title 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
Date of disclosure of the study information 2018/02/21
Last modified on 2018/02/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym A random-control study of CART using PMMA membrane against patients with refractory ascites
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuteru Kitade
Organization Nara Medical University
Division name Third Department of Internal Medicine
Zip code
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744223051
Email kitadem@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuteru Kitade
Organization Nara Medical University
Division name Third Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.