UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006886 |
|---|---|
| Receipt number | R000008135 |
| Scientific Title | The accuracy of noninvasive and continuous total hemoglobin measurement by pulse CO-Oxymetry undergoing hemodilution autologous transfusion |
| Date of disclosure of the study information | 2011/12/14 |
| Last modified on | 2011/12/13 22:33:28 |
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Basic information
Public title
The accuracy of noninvasive and continuous total hemoglobin measurement by pulse CO-Oxymetry undergoing hemodilution autologous transfusion
Acronym
Investigation for the accuracy of noninvasive and continuous total hemoglobin measurement
Scientific Title
The accuracy of noninvasive and continuous total hemoglobin measurement by pulse CO-Oxymetry undergoing hemodilution autologous transfusion
Scientific Title:Acronym
Investigation for the accuracy of noninvasive and continuous total hemoglobin measurement
Region
| Japan |
Condition
Condition
surgical patients with malignant tumor
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether noninvasive hemoglobin measurement by pulse CO-Oxymetry could provide clinically acceptable absolute and trend accuracy in surgical patients undergoing hemodilutional autologous transfusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of noninvasive hemoglobin measurement
Key secondary outcomes
The effect of several variables on the accuracy of noninvasive hemoglobin measurement
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who were scheduled to undergo hemodilutional autologous transfusion during the urological and gynecological surgery
Key exclusion criteria
Preoperative hemoglobin < 11 g/dl
A past history of ischemic heart disease and/or central nervous systemic illness
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Kitayama |
Organization
Hirosaki university hospital
Division name
Anesthesiology
Zip code
Address
53 Hon-cho, Hirosaki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hirosaki University Graduate School of medicine, Hirosaki, Japan
Division name
Department of anesthesiology
Zip code
Address
TEL
Homepage URL
masuika@cc.hirosaki-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Hirosaki University Graduate School of Medicine
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
| 2011 | Year | 12 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, there was no adverse effect to the patient.
Management information
Registered date
| 2011 | Year | 12 | Month | 13 | Day |
Last modified on
| 2011 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008135
