Unique ID issued by UMIN | UMIN000031393 |
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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 |
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
A random-control study of CART using PMMA membrane against patients with refractory ascites
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
A random-control study of CART using PMMA membrane against patients with refractory ascites
Japan |
refractory ascites
Hepato-biliary-pancreatic medicine |
Others
NO
To assess the usefulness of PMMA membrane as a filtration agent in CART against patients against refractory ascites
Efficacy
Exploratory
Pragmatic
Not applicable
fever up within 24 hours after CART
duration of next CART session
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Device,equipment |
Polystyrene(PS) membrane group
Use polystyrene membrane when concentrating ascites before performing CART. Use day 1 only.
polymethylmethacrylate(PMMA) membrane group
Use polymethylmethacrylate membrane when concentrating ascites before performing CART. Use day 1 only.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
20
1st name | |
Middle name | |
Last name | Mitsuteru Kitade |
Nara Medical University
Third Department of Internal Medicine
840 Shijo-cho, Kashihara, Nara
0744223051
kitadem@naramed-u.ac.jp
1st name | |
Middle name | |
Last name | Mitsuteru Kitade |
Nara Medical University
Third Department of Internal Medicine
840 Shijo-cho, Kashihara, Nara
0744223051
kitadem@naramed-u.ac.jp
Third Department of Internal Medicine, Nara Medical University
Third Department of Internal Medicine, Nara Medical University
Self funding
NO
2018 | Year | 02 | Month | 21 | Day |
Unpublished
Open public recruiting
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2018 | Year | 02 | Month | 20 | Day |
2018 | Year | 02 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035506
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