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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025382
Receipt No. R000029223
Scientific Title The optimal ultrafiltration method in cell-free and concentrated ascites reinfusion therapy
Date of disclosure of the study information 2017/01/04
Last modified on 2018/09/03

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Basic information
Public title The optimal ultrafiltration method in cell-free and concentrated ascites reinfusion therapy
Acronym The optimal ultra filtration method in CART
Scientific Title The optimal ultrafiltration method in cell-free and concentrated ascites reinfusion therapy
Scientific Title:Acronym The optimal ultra filtration method in CART
Region
Japan

Condition
Condition Patients with refractory cancerous ascites
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the optimal ultrafiltration method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The time to reach the set pressure (TMP500mmHg)
Key secondary outcomes 1. The serial change of transmembrane pressure and ascites weight
2. Analysis of the original ascites and the filtered ascites
3. Analysis of the filter

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 concentrated ascites reinfusion therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients with refractory cancerous as cites who are judged as the indication of CART

2. The first CART for the patient

3. The patients who can recognize the study and express the agreement by the document.
Key exclusion criteria 1. Patients with ascites contaminated by endotoxin
2. Severe immunocompromized patients
3. Patients who have peritoneo-venous shunt
4. Patients who have transjugular intrahepatic portosystemic shunt
5. Infection; Syphilis HBs antigen HBc antibody HCV HIV01,2 HTLV1
6. Patients who are judged as the inappropriate for this study by the doctor.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Midori Hasegawa
Organization Fujita Health University School of Medicine
Division name Department of Nephrology
Zip code
Address 1-98 Dengakugakubo Kutsukakecho Toyoakeshi Aichi
TEL 0562-93-9245
Email mhase@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Midori Hasegawa
Organization Fujita Health University School of Medicine
Division name Department of Nephrology
Zip code
Address 1-98 Dengakugakubo Kutsukakecho Toyoakeshi Aichi
TEL 0562-93-9245
Homepage URL
Email mhase@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization Other
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
2017 Year 01 Month 04 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 Completed
Date of protocol fixation
2015 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 03 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
2016 Year 12 Month 22 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029223

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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