UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048919 |
|---|---|
| Receipt number | R000055738 |
| Scientific Title | Donation check lists on ER arrival as a facilitated registry system for corneal donation |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2022/09/12 19:19:36 |
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Basic information
Public title
Donation check lists on ER arrival as a facilitated registry system for corneal donation
Acronym
Donation check lists on ER arrival as a facilitated registry system for corneal donation
Scientific Title
Donation check lists on ER arrival as a facilitated registry system for corneal donation
Scientific Title:Acronym
Donation check lists on ER arrival as a facilitated registry system for corneal donation
Region
| Japan |
Condition
Condition
Cardiopulmonary arrest. Fatal condition.
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By investigating the indications and intentions regarding corneal donation in all cases, we will grasp the full picture of corneal donation in our emergency department.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients confirmed dead in the emergency department whose eligibility for corneal donation was evaluated by a healthcare provider
Key secondary outcomes
Number of cases that meet indications for corneal donation.
Number of patients who wish to donate corneas.
Epidemiological investigation of reasons why corneal donation is not indicated
Epidemiological investigation of the reason why the desired corneal donation was not implemented
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases confirmed dead in the emergency department
Key exclusion criteria
1)Cases without medical indications
Hematological disease, presence of severe infection, various known infectious diseases (HBV, HCV, HIV, HTLV-1), corneal clouding and injury, cause of death unknown, drowning
2)Cases with no social adaptation
Incidental-abuse/harm to others, unidentified body, absence of bereaved family/no contact, more than 12 hours from time of death to time of corneal extraction
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Haruaki |
| Middle name | |
| Last name | Wakatake |
Organization
St. Marianna University Yokohama Seibu Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
241-0811
Address
1197-1, Yasashi-cho, Asahi-ku, Yokohama 241-0811
TEL
045-366-1111
haruwakatake@gmail.com
Public contact
Name of contact person
| 1st name | Haruaki |
| Middle name | |
| Last name | Wakatake |
Organization
St. Marianna University Yokohama Seibu Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
241-0811
Address
1197-1, Yasashi-cho, Asahi-ku, Yokohama 241-0811
TEL
045-366-1111
Homepage URL
haruwakatake@gmail.com
Sponsor or person
Institute
St. Marianna University School of Medicine
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
St. Marianna University Yokohama Seibu Hospital
Address
1197-1, Yasashi-cho, Asahi-ku, Yokohama 241-0811
Tel
045-366-1111
haruwakatake@gmail.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
| 2022 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2042 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All-case survey using a checklist (intervention test for medical personnel)
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055738
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
