UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025382
Receipt number 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 10:07:05

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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 or person

Institute

Fujita Health University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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