UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006173 |
|---|---|
| Receipt number | R000007296 |
| Scientific Title | Assessment of pain after subcutaneous erythropoietin injection in patients undergoing autologous blood transfusion |
| Date of disclosure of the study information | 2011/08/15 |
| Last modified on | 2011/08/15 15:10:56 |
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Basic information
Public title
Assessment of pain after subcutaneous erythropoietin injection in patients
undergoing autologous blood transfusion
Acronym
Assessment of pain after subcutaneous erythropoietin injection in patients
undergoing autologous blood transfusion
Scientific Title
Assessment of pain after subcutaneous erythropoietin injection in patients
undergoing autologous blood transfusion
Scientific Title:Acronym
Assessment of pain after subcutaneous erythropoietin injection in patients
undergoing autologous blood transfusion
Region
| Japan |
Condition
Condition
autorogous blood transfusion
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of pain after subcutaneous erythropoietin injection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS
Visual Analog Scale
Key secondary outcomes
FRS
Wrong-Baker Faces Pain Rating Scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group:EPO A-EPO B
Interventions/Control_2
B group:EPO B-EPO A
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1:patient who operation will be scheduled in the future
*saving 800mL autorogous blood transfusion
*adjustment of indication of autorogous blood transfusion in our Hospital
A;Indication of autorogous blood transfusion
1;good general condition and elective surgery
2;Operation that needs blood transfusion
3;Rare blood type and irregular antibody
4;Patient who understand autorogous blood transfusion
B;standard value
1.Age ;no restriction
2.Weight ;no restriction
3.CBC;Hb>11.0g/dl,Ht>33%
4.Vitalsign;BT>37.2,50<HR<120,90<BP<170
2:patient who was administered erythropoietin over 2times
3:20-85
4:patient who agreed as for the participation of the examination.
Key exclusion criteria
1,Allergy for erythropoietin
2,Patient who cannot normally recognize pain
3,Patient whom doctor judged to be undesirable as object of examination
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SOICHI TSUJI |
Organization
St.Luke's International Hospital
Division name
Orthopedic surgery
Zip code
Address
9-1.Akashi-cho,Chuo-ku,Tokyo,Japan
TEL
03-3541-5151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayano Miyake |
Organization
St.Luke's international Hospital
Division name
Research cetter
Zip code
Address
TEL
Homepage URL
miaya@luke.or.jp
Sponsor or person
Institute
St.Luke's International Hospital
Research center
Institute
Department
Personal name
Funding Source
Organization
none
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 | 08 | Month | 15 | 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
| 2011 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 15 | Day |
Last modified on
| 2011 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007296
