UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033999
Receipt No. R000038771
Official scientific title of the study 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 2018/09/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Evaluation of reliability of non-invasive hemoglobin measurement in patients undergoing major orthopedic surgery: Prospective observational study
Title of the study (Brief title) 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 Sang Sik Choi
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Address 148 Gurodong-ro, Guro-gu, Seoul 08308
TEL 82-2-2626-3237
Email clonidine@empas.com

Public contact
Name of contact person Hae Wone Chang
Organization Korea University Guro Hospital
Division name Anesthesiology and Pain Medicine
Address 148 Gurodong-ro, Guro-gu, Seoul 08308
TEL 82-2-2626-3237
Homepage URL
Email chelenh@gmail.com

Sponsor
Institute Korea University Guro Hospital
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 13 Day
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.