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Recruitment status Terminated
Unique ID issued by UMIN UMIN000012161
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email a-t1@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014215


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