UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022279 |
|---|---|
| Receipt number | R000025672 |
| Scientific Title | The effect of hemodilution with various isotonic solution |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2016/11/15 16:06:44 |
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Basic information
Public title
The effect of hemodilution with various isotonic solution
Acronym
The effect of hemodilution with various isotonic solution
Scientific Title
The effect of hemodilution with various isotonic solution
Scientific Title:Acronym
The effect of hemodilution with various isotonic solution
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the hemodilution with various isotonic solution
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activatd clotting time,clot rate,platelet function are investigated using Sonoclot
Key secondary outcomes
coagulation parameters
PT,APTT,Ht,platelet,Factor8,von Willebrand Factor,fibrinogen,AT3
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
Key inclusion criteria
healthy volunteers
Key exclusion criteria
coagulation defects
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki
TEL
072-683-1221
ane022@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Nakao |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki
TEL
072-683-1221
Homepage URL
ane086@osaka-med.ac.jp
Sponsor or person
Institute
Department of Anesthesiology,Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology,Osaka Medical College
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
大阪医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 11 | 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 | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025672
