UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019341 |
|---|---|
| Receipt number | R000022230 |
| Scientific Title | The usefulness of pulse hemoglobin measurements using co-oximeter in patients undergoin total hip arthroplastyor total knee arthroplasty |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2015/12/16 17:53:06 |
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Basic information
Public title
The usefulness of pulse hemoglobin measurements using co-oximeter in patients undergoin total hip arthroplastyor total knee arthroplasty
Acronym
The usefulness of pulse hemoglobin measurements using co-oximeter in patients undergoing THA and TKA
Scientific Title
The usefulness of pulse hemoglobin measurements using co-oximeter in patients undergoin total hip arthroplastyor total knee arthroplasty
Scientific Title:Acronym
The usefulness of pulse hemoglobin measurements using co-oximeter in patients undergoing THA and TKA
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee or the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the utility of pulse hemoglobin measurements using CO-Oximeter in patients undergoing total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total time of postoperative Hb<target Hb
Key secondary outcomes
postoperative blood pressure, heart rate, blood loss, urine volume and cardiovascular event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Patients of control group are managed monitoring the SpHb.
Interventions/Control_2
Patiens of observation group was managed as has been the way until now.
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 undergo total hip arthroplasty or total knee arthroplasty.
Patients agree to the informed consent.
Key exclusion criteria
Patients who has hyperbilirubinemia or peripheral vascular desease.
The researcer judged the patients inappropriate.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Yamaura |
Organization
Fukuoka University
Division name
depertment of anesthesiology
Zip code
Address
7-45-1, Nanakuma, Jonan-ku,Fukuoka-shi,Fukuoka.
TEL
092-801-1011
kenyamaura@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Erisa Nakamori |
Organization
Fukuoka university
Division name
department of anesthesiology
Zip code
Address
7-45-1, Nanakuma, Jonan-ku,Fukuoka-shi,Fukuoka.
TEL
092-801-1011
Homepage URL
erisanakamori@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | 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
Management information
Registered date
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2015 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022230
