UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033999 |
|---|---|
| Receipt number | R000038771 |
| Scientific Title | Evaluation of reliability of non-invasive hemoglobin measurement in patients undergoing major orthopedic surgery: Prospective observational study |
| Date of disclosure of the study information | 2018/09/03 |
| Last modified on | 2020/03/18 10:38:39 |
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Basic information
Public title
Evaluation of reliability of non-invasive hemoglobin measurement in patients undergoing major orthopedic surgery: Prospective observational study
Acronym
Non-invasive hemoglobin measurement in patients undergoing major orthopedic surgery
Scientific Title
Evaluation of reliability of non-invasive hemoglobin measurement in patients undergoing major orthopedic surgery: Prospective observational study
Scientific Title:Acronym
Non-invasive hemoglobin measurement in patients undergoing major orthopedic surgery
Region
| Asia(except Japan) |
Condition
Condition
Recruiting
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the reliability of SpHb during major orthopedic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between SpHb and
arterial hemoglobin (POC device and central core lab)
Key secondary outcomes
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
| 19 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hip surgery, Pelvis surgery, Femur Fx, Tibia Fx, Knee replacement surgery, Knee amputation surgery
Key exclusion criteria
Hb less than 10 g/dL
Chronic kidney disease
Chronic liver disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sang Sik |
| Middle name | |
| Last name | Choi |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
08308
Address
148 Gurodong-ro, Guro-gu, Seoul 08308
TEL
82-2-2626-3237
clonidine@empas.com
Public contact
Name of contact person
| 1st name | Hae Wone |
| Middle name | |
| Last name | Chang |
Organization
Korea University Guro Hospital
Division name
Anesthesiology and Pain Medicine
Zip code
08308
Address
148 Gurodong-ro, Guro-gu, Seoul 08308
TEL
82-2-2626-3237
Homepage URL
chelenh@gmail.com
Sponsor or person
Institute
Korea University Guro Hospital
Institute
Department
Personal name
Funding Source
Organization
Korea University Guro Hospital
Anesthesiology and Pain Medicine
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
Korea University Guro Hospital Institutional Review Board
Address
148 Gurodong-ro, Guro-gu, Seoul 08308
Tel
82226261632
kughirb@naver.com
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
| 2018 | Year | 09 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
difference between SpHb and arterial hemoglobin during perioperative perioids
Management information
Registered date
| 2018 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038771
