UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019668 |
|---|---|
| Receipt number | R000022412 |
| Scientific Title | Prospective intervention study for drainage of subretinal hemorrhage using tissue plasminogen activator |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2015/11/24 13:33:46 |
* 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
Public title
Prospective intervention study for drainage of subretinal hemorrhage using tissue plasminogen activator
Acronym
Prospective intervention study for drainage of subretinal hemorrhage using tissue plasminogen activator
Scientific Title
Prospective intervention study for drainage of subretinal hemorrhage using tissue plasminogen activator
Scientific Title:Acronym
Prospective intervention study for drainage of subretinal hemorrhage using tissue plasminogen activator
Region
| Japan |
Condition
Condition
subretinal hemorrhage
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to comfirm efficiency of drainage of subretinal hemorrhage using tissue plasminogen activator
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of improvement of postoperative clinical presentations
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
injection to vitreous cavity 45000IU/0.3ml
injection to subretinal cavity 3000/0.02ml-30000/0.2ml
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who fills all following clinical features are objected.
1) subretinal hemorrhage
2) more than 16-year-old person
3) male and female
4) well informed-consented person
5) hospitalizing and foreignness
6) even participates in other clinical study or not
Key exclusion criteria
Patient who fills any following clinical features are not applicable.
1) the patient who judged that prescription wasn't desirable for other ocular diseases or whole body diseases
2) the patient who judged unsuitable as a subject
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kimura |
Organization
Yamaguchi University Hospital
Division name
ophthalmology
Zip code
Address
Minami-Kogushi 1-1-1, Ube, Yamaguchi
TEL
0836-22-2278
k.kimura@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kimura |
Organization
Yamaguchi University Hospital
Division name
ophthalmology
Zip code
Address
Minami-Kogushi 1-1-1, Ube, Yamaguchi
TEL
0836-22-2278
Homepage URL
k.kimura@yamaguchi-u.ac.jp
Sponsor or person
Institute
ophthalmology department of Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
trust accounts of ophthalmology department of Yamaguchi University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 06 | 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
| 2014 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 20 | 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
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022412
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
