UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031393
Receipt number 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 18:13:42

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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 or person

Institute

Third Department of Internal Medicine, Nara Medical University

Institute

Department

Personal name



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

Value
https://center6.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