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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001074
Receipt No. R000001306
Scientific Title Autologous plasma transfusion in liver resection for hepatocellular carcinoma
Date of disclosure of the study information 2008/03/21
Last modified on 2014/03/15

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Basic information
Public title Autologous plasma transfusion in liver resection for hepatocellular carcinoma
Acronym Autologous plasma transfusion in liver resection
Scientific Title Autologous plasma transfusion in liver resection for hepatocellular carcinoma
Scientific Title:Acronym Autologous plasma transfusion in liver resection
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of predeposit autologous plasma donation and its efficacy in avoiding allogenic blood transfusions in liver resection for hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Serum total protein/alubumin values and liver synthetic function during plasma donations and perioperative allogenic blood transfusion rates
Key secondary outcomes Postoperative immune function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Predeposit autologous plasma donation before liver resection
Interventions/Control_2 No autologous plasma donation before liver resection
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Child-Pugh class A cirrhosis and indocyanine green retention rate at 15 minutes <= 15%
Key exclusion criteria Patients with a serum albumin level of less than 3.0 g/dL, a hemoglobin level of less than 11.0 g/dL, or a body weight of less than 40 kg
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeaki Ishizawa
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
TEL
Homepage URL
Email tish-tky@umin.ac.jp

Sponsor
Institute University of Tokyo Hospital
Institute
Department

Funding Source
Organization University of Tokyo Hospital
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
2008 Year 03 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 Completed
Date of protocol fixation
2006 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 03 Month 13 Day
Last modified on
2014 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001306

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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