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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019341
Receipt No. 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

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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
Email 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
Email erisanakamori@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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