UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012161 |
|---|---|
| Receipt number | R000014215 |
| Scientific Title | local intraarterial fibrinolysis in central retinal arteryy occlusion |
| Date of disclosure of the study information | 2013/10/30 |
| Last modified on | 2016/05/01 11:04:57 |
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Basic information
Public title
local intraarterial fibrinolysis in central retinal arteryy occlusion
Acronym
LIF in CRAO
Scientific Title
local intraarterial fibrinolysis in central retinal arteryy occlusion
Scientific Title:Acronym
LIF in CRAO
Region
| Japan |
Condition
Condition
central retinal artery occlusion
Classification by specialty
| Neurology | Ophthalmology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the proof of the efficacy of local intraarterial fibrinolysis in central retinal artery occlusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. improvement of vision 48 hours after the treatment
2. improvement of vision 2 weeks after the treatment
Key secondary outcomes
1. improvement of angiographic visualization of optic artery after treatment
2. improvement of fundus examination after treatment
3. complication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
local intraarterial fibrinosys using urokinase
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Aged 18 and over
2)Within 15 hours after development of symptoms
3)Visual acuity is 20/400 or loss
4)The case in which visual acuity improvement is not obtained under medical treatment (eye massage) conventionally which was performed by the time it resulted in endovascular treatment
5)The case which accepts the occlusion of clear CRA in fundus examination
Key exclusion criteria
1)improvement of visual acuity before treatment
2)the case in which the difficulty is became clear by examination before treatment for the approach to an ophthalmic artery
3)the case in which cerebral hemorrhage is diagnosed by examination before treatment
4)When a systemic bleeding disorder exists within three months
5)When consent acquisition for treatment cannot be carried out
6)The case diagnosed as angitis clinically or on examination
7)When the phenomenon remarkably being difficultty for treatment exists
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | naoshi ide |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Ophthalmology
Zip code
Address
1197-1, yasashicho, yokohama asahi-ku, kanagawa
TEL
045-366-1111
n2ide@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | atsushi tsuchiya |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
neurology
Zip code
Address
1197-1, yasashicho, yokohama asahi-ku, kanagawa
TEL
045-366-1111
Homepage URL
a-t1@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
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
聖マリアンナ医科大学横浜市西部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2016 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014215
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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