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Trial registered on ANZCTR


Registration number
ACTRN12608000441314
Ethics application status
Approved
Date submitted
23/08/2008
Date registered
3/09/2008
Date last updated
12/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of the efficacy of intravenous tissue plasminogen activator (tPA) in the treatment of acute central retinal artery occlusion (CRAO)
Scientific title
Study of the efficacy of intravenous tissue plasmiogen activator (tPA) in the treatment of acute central retinal artery occlusion (CRAO)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinalvascular disease 3600 0
Central Retinal Artery Occlusion - Acute stroke of the eye 3614 0
Condition category
Condition code
Stroke 3759 3759 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous infusion of tissue plasimonogen activator (tPA) versus standard therapy
Tissue plasminogen activator will be given at dosage of 0.9mg/kg in 100ml of normal saline over 1 hour. Standard therapy group will be given placebo therapy of Normal saline 100ml over 1 hour. The therapy will be randomised in a 1:1 ratio using a block randomization schedule. The infusion will be covered in black cover for masking.
Intervention code [1] 3314 0
Treatment: Drugs
Comparator / control treatment
Standard Therapy group will be given Normal saline infusion 100ml over 1 hour.
Control group
Placebo

Outcomes
Primary outcome [1] 4655 0
Greater than or equal to 3 lines of visual acuity on Snellen visual acuity chart or equivalent conversion
Timepoint [1] 4655 0
6 months
Secondary outcome [1] 7870 0
1. Visual fields using Humphry Visual Field Analyser with SITA-Standard 24-2 strategy in those with visual acuity greater or equal to 6/60.
2. Nerve fiber layer thinning using Optical coherence topography at 6 months compared to baseline.
Timepoint [1] 7870 0
at 6 months
Secondary outcome [2] 262238 0
Visual acuity change of 3 lines or more according time to presentation between 0-6 hours, 6-12 hours and 12-24 hours.
Timepoint [2] 262238 0
at 6 months.
Secondary outcome [3] 262239 0
Visual acuity change on Snellen Chart or equivalent converstion
Timepoint [3] 262239 0
At 1 day, 1 month, 3 months and 6 months

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Age greater than or equal to 18 years old
2. Acute central retinal artery occluasion (CRAO) within 24 hours of onset of symptoms (ie within 24hours of last know time with normal vision)
3. A presumed thromboembolic cause
4. No evidence of temporal arteritis by clinical assessment or laboratory studies (e.g., erythrocyte sedimentation rate [ESR])
5. Non-contrast computerized tomography (CT) brain demonstrating no acute intra-cranial haemorrhage, infarction or mass lesion
6. Computerized tomography angiography (CTA) demonstrating no ipsilateral carotid artery occlusion.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Uncertain time of CRAO onset
-A current or previous history of systemic hemorrhage within the last 12 months
-Computerised tomography (CT) of the brain showing evidence of intracranial hemorrhage
-Clinical evidence of CRAO from giant cell arteritis
-Inability to obtain subject consent
-Clinical, biochemical or imaging predictors of increased risk of intracerebral hemorrhage including :
o Brain CT shwoing early ischemic changes of greater 1/3 of the middle cerebral artery territory
o Brian CT showing an arterial hyperdensity on proximal internal carotid artery
o Major surgery or serious trauma in the last 2 weeks
o Gastrointestinal or urinary bleeding within 3 weeks
o Arterial puncture or lumbar puncture within the 7 days.
o A platelet count of <100
o Heparin administered within the last 48 hours or vitamin K antagonist for an INR of >1.7
o Age >80
o Systolic blood pressure of >185 and diastolic blood pressure of >110
o A glycaemic value >400mg/dl (22.22mmol/L)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomised in a 1:1 ratio using a block randomization schedule to receive either tissue plasminogen activator (tPA) or Placebo (normal saline) in an intravenous bag covered in black cover for masking. The randomiser is an in-build computer program within an on-line web database and patient is assigned the treatment group after registration and confirmation of eligibility. A concealed print-out of treatment allocation will be passed to the ED nurse instructing the dose of tPA or placebo to be prepared. The treatment (tPA versus placebo) will be concealed to the neurologist, ophthalmologist and trial data collector/analyser.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to generate the sequence in which the subject is randomised is by simple randomisation by using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3776 0
Hospital
Name [1] 3776 0
Flinders Medical Centre
Address [1] 3776 0
Flinders Drive
Bedford Park
South Australia 5042
Country [1] 3776 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 3387 0
University
Name [1] 3387 0
Flinders University
Address [1] 3387 0
Bedford Drive
Bedford Park SA 5042
Country [1] 3387 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5839 0
Southern Adelaide Health Service / Flinders University
Ethics committee address [1] 5839 0
Flinder Drive
Bedford Park
South Australia 5042
Ethics committee country [1] 5839 0
Australia
Date submitted for ethics approval [1] 5839 0
Approval date [1] 5839 0
21/07/2008
Ethics approval number [1] 5839 0
07/08
Ethics committee name [2] 244116 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [2] 244116 0
32 Gisborne Street
East Melbourne
Victoria 3002 AUSTRALIA
Ethics committee country [2] 244116 0
Australia
Date submitted for ethics approval [2] 244116 0
01/07/2009
Approval date [2] 244116 0
10/11/2009
Ethics approval number [2] 244116 0
09/893H
Ethics committee name [3] 244117 0
St. Vincent's Hospital Melbourne - HREC D
Ethics committee address [3] 244117 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [3] 244117 0
Australia
Date submitted for ethics approval [3] 244117 0
01/07/2009
Approval date [3] 244117 0
10/11/2009
Ethics approval number [3] 244117 0
096/09

Summary
Brief summary
Central retinal artery occlusion (CRAO) is an eye Stroke, usually caused by the blood vessel supplying the eye being blocked, resulting in the eye not working. Usually, once the eye stroke occurs, the vision in the eye is severely affected and recovery is minimal. Unfortunately, most standard treatments at the moment do not improve vision. On average, most patient are not able to see the biggest letter on the eye chart out of the affected eye after the eye stroke.

Some centres overseas have looked at using the medication used in heart attack (tPA) in eye stroke using a procedure to deliver the medication to the blocked blood vessel. The results are preliminary but promising. Most of the studies delivers the drug through an invasive procedure to deliver the medication close to where the blood vessel blockage is near the eye. Another way to deliver the medication is through a drip. This is the method for treatment in acute stroke of the brain when people present within a certain time window.
This study aims to see if admininstration of the medication through a drip may improve the vision in acute eye stroke yet reducing the side effects of bleeing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28871 0
Address 28871 0
Country 28871 0
Phone 28871 0
Fax 28871 0
Email 28871 0
Contact person for public queries
Name 12028 0
Dr. Celia Chen
Address 12028 0
Department of Ophthalmology
Flinders Medical Centre and Flinders University
Bedford Drive, Bedford Park
South Australia 5042
Country 12028 0
Australia
Phone 12028 0
(08) 82044899
Fax 12028 0
(08) 82770899
Email 12028 0
Celia.Chen@health.sa.gov.au
Contact person for scientific queries
Name 2956 0
Dr. Celia Chen
Address 2956 0
Department of Ophthalmology
Flinders Medical Centre and Flinders University
Bedford Drive, Bedford Park
South Australia 5042
Country 2956 0
Australia
Phone 2956 0
(08) 82044899
Fax 2956 0
(08) 82770899
Email 2956 0
celia.chen@fmc.sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results