UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011093 |
|---|---|
| Receipt number | R000012991 |
| Scientific Title | A study on low invasive hemodynamic monitors in hemodilutional autologous blood transfusion. |
| Date of disclosure of the study information | 2013/07/02 |
| Last modified on | 2013/07/02 10:20:35 |
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Basic information
Public title
A study on low invasive hemodynamic monitors in hemodilutional autologous blood transfusion.
Acronym
Homodynamic Monitors in HAT
Scientific Title
A study on low invasive hemodynamic monitors in hemodilutional autologous blood transfusion.
Scientific Title:Acronym
Homodynamic Monitors in HAT
Region
| Japan |
Condition
Condition
Patient undergoing surgery with general anesthesia
Classification by specialty
| Anesthesiology | Blood transfusion | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate safety and efficacy of hemodilutional autologous blood transfusion using low invasive hemodynamic monitors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial Pressure, Cardiac output, Stroke volume
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 | Device,equipment |
Interventions/Control_1
Aftter induction of general anesthesia, autologous blood (around 800g) will be collected in normovolemic hemodilution manner. CVS parameter mentioned will be measured.
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
Patient who informed consent and agreed to the protocol
Key exclusion criteria
Patient who informed consent and does not agreed to the protocol.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogawawara Chihiro |
Organization
Hirosaki Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Zaifu5, Hirosaki, Aomori
TEL
0172335111(4290)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ogawawara Chihiro |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 07 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 03 | 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
| 2013 | Year | 07 | Month | 02 | Day |
Last modified on
| 2013 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012991
