UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019945 |
|---|---|
| Receipt number | R000023030 |
| Scientific Title | The effects of the hemodilution with the third generation 6%HES130/0.4/9(Voluven®) |
| Date of disclosure of the study information | 2015/11/27 |
| Last modified on | 2017/06/04 16:45:53 |
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Basic information
Public title
The effects of the hemodilution with the third generation 6%HES130/0.4/9(Voluven®)
Acronym
The effects of the hemodilution with the third generation 6%HES130/0.4/9(Voluven®)
Scientific Title
The effects of the hemodilution with the third generation 6%HES130/0.4/9(Voluven®)
Scientific Title:Acronym
The effects of the hemodilution with the third generation 6%HES130/0.4/9(Voluven®)
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the hemodilution with Voluven in vitro
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
coagulation parameters
ACT,PT,APTT,Ht,platelet,Factor8,fibrinogen,AT3
Key secondary outcomes
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
blood sampling
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
Healthy volunteers
Key exclusion criteria
coagulation defects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisanari Ishii |
Organization
Tenri Hospital
Division name
Department of Anesthesia
Zip code
Address
200 Mishima-cho, Tenri, Nara 632-8555, Japan
TEL
0743-63-5611
hisanari@tenriyorozu.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Nakao |
Organization
Tenri Hospital
Division name
Department of Anesthesia
Zip code
Address
200 Mishima-cho, Tenri, Nara 632-8555, Japan
TEL
0743-63-5611
Homepage URL
ane086@osaka-med.ac.jp
Sponsor or person
Institute
Tenri Hospital
Institute
Department
Personal name
Funding Source
Organization
Tenri Hospital
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
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
| 2015 | Year | 11 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 21 | 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
| 2015 | Year | 11 | Month | 27 | Day |
Last modified on
| 2017 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023030
