UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033096 |
|---|---|
| Receipt number | R000037735 |
| Scientific Title | A prevention system for the blood donation related neuropathic pain (BDRNP)- prospective multi-center study |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2018/06/21 23:58:41 |
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Basic information
Public title
A prevention system for the blood donation related neuropathic pain (BDRNP)- prospective multi-center study
Acronym
A prevention system for the blood donation related neuropathic pain (BDRNP)
Scientific Title
A prevention system for the blood donation related neuropathic pain (BDRNP)- prospective multi-center study
Scientific Title:Acronym
A prevention system for the blood donation related neuropathic pain (BDRNP)
Region
| Japan |
Condition
Condition
neuropathic pain
Classification by specialty
| Medicine in general | Orthopedics | Anesthesiology |
| Blood transfusion | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the SFCPD hypothesis and investigate our intervention, including the SAEFP test, prior to blood donation and information provided to test-positive donors, which provides them with an opportunity to refuse donation following this knowledge.
Basic objectives2
Others
Basic objectives -Others
prospective multi center study using SAEFP test and manual
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the occurrence of BDRNP
Key secondary outcomes
Pain duration or severity of BDRNP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Shoulder abduction Elbow Flexion Phalen test (SAEFP test)
Interventions/Control_2
Test manual for SAEFP test -positive donors
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
| 16 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All Blood donator
Key exclusion criteria
donator who refused SAEFP test
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji iNADA |
Organization
Inada hospital
Division name
orthopedic procedure
Zip code
Address
46 Ohmoricho,Nara city,Nara Nara Japan
TEL
81-742-23-8815
yuji-829@ja2so-net.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Inada |
Organization
Ina Hospital
Division name
orthopedic surgery
Zip code
Address
46 ohmoricho Nara 630 Japan
TEL
81-742-23-8815
Homepage URL
yuji-829@ja2.so-net.ne.jp
Sponsor or person
Institute
Japanease Redd Cross
Institute
Department
Personal name
Funding Source
Organization
Japanease Redd Cross
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
関西地区血液センター（大阪、奈良、兵庫、京都、和歌山）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
In conclusion, we found that the total number, including severe cases, of BDRNP; and total number of BDRNP cases without cutaneous nerve injury, were significantly reduced when compared with those in the previous 5 years. Based on previous pilot studies and these results, the SFCPD hypothesis was accepted as mechanism of BDRNP. To the best of our knowledge, our cost-free and convenient preliminary intervention including SAEFP test based on the SFCPD hypothesis, is the first study to report improvements in the occurrence of BDRNP.
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 21 | 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
| 2018 | Year | 06 | Month | 22 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037735
