UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001164 |
|---|---|
| Receipt number | R000001422 |
| Scientific Title | Platelet transfusion therapy against chronic hepatitis and liver cirrhosis |
| Date of disclosure of the study information | 2008/06/03 |
| Last modified on | 2013/05/23 13:37:02 |
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Basic information
Public title
Platelet transfusion therapy against chronic hepatitis and liver cirrhosis
Acronym
Platelet transfusion therapy against chronic hepatitis and liver cirrhosis
Scientific Title
Platelet transfusion therapy against chronic hepatitis and liver cirrhosis
Scientific Title:Acronym
Platelet transfusion therapy against chronic hepatitis and liver cirrhosis
Region
| Japan |
Condition
Condition
chronic hepatitis
liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal safety and efficacy of liver regeneration and anti-fibrotic effect of platelet transfusion on the chronic hepatitis and liver cirrhosis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
fibrosis markers: type IV collagen, hyarulonic acid, PIIIP
liver function: albumin, AST, ALT, bilirubin, prothrombin time
Key secondary outcomes
abdominal ultrasonography and CT
platelet count
anti-platelet antibody
amount of hepatitis virus
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
platelet transfusion
10U/week, 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)chronic hepatitis or Child-Pugh grade A or B
2)no malignancy
3)PS 0 or PS 1
4)no serious cardiovascular disease
5)agreement by documents
6)platelet counts were around 50 to 100
thousand/microlitter in previous year
Key exclusion criteria
1)platelet count was less than 50
thousand/microlitter in the latest data
2)past history of shock on platelet transfusion
3)bone marrow transplantation(exept auto-transplantation) recipient or immunosuprrsive patients
4)IgA deficiency or other plasma protein deficiency
5)women with pregnancy, lactation or willing to get pregnant
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ohkohchi |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ohkohchi |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3221
Homepage URL
nokochi3@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/tjem/229/3/229_213/_pdf
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/tjem/229/3/229_213/_pdf
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
| 2008 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 05 | Month | 23 | Day |
Last modified on
| 2013 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001422
