UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001074 |
|---|---|
| Receipt number | 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 00:09:28 |
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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
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
tish-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001306
