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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
16/06/2021
Date data sharing statement initially provided
16/06/2021
Date results information initially provided
16/06/2021
Type of registration
Prospectively 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)
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Scientific title
Study of the efficacy of intravenous tissue plasmiogen activator (tPA) in the treatment of acute central retinal artery occlusion (CRAO)
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Secondary ID [1]
304495
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Retinalvascular disease
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Central Retinal Artery Occlusion - Acute stroke of the eye
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Condition category
Condition code
Stroke
3759
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0
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Ischaemic
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
3314
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Treatment: Drugs
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Comparator / control treatment
Standard Therapy group will be given Normal saline infusion 100ml over 1 hour.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Greater than or equal to 3 lines of visual acuity on Snellen visual acuity chart or equivalent conversion
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Assessment method [1]
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Timepoint [1]
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6 months
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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at 6 months
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Secondary outcome [2]
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Visual acuity change of 3 lines or more according time to presentation between 0-6 hours, 6-12 hours and 12-24 hours.
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Assessment method [2]
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Timepoint [2]
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at 6 months.
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Secondary outcome [3]
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Visual acuity change on Snellen Chart or equivalent converstion
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Assessment method [3]
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Timepoint [3]
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At 1 day, 1 month, 3 months and 6 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2008
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Actual
1/01/2009
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Date of last participant enrolment
Anticipated
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Actual
1/07/2011
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Date of last data collection
Anticipated
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Actual
1/07/2011
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Sample size
Target
16
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Flinders Medical Centre
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Address [1]
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Flinders Drive
Bedford Park
South Australia 5042
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Flinders Medical Centre
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Address
Flinders Drive
Bedford Park
South Australia 5042
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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Flinders University
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Address [1]
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Bedford Drive
Bedford Park SA 5042
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Adelaide Health Service / Flinders University
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Ethics committee address [1]
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Flinder Drive
Bedford Park
South Australia 5042
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
5839
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Approval date [1]
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21/07/2008
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Ethics approval number [1]
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07/08
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Ethics committee name [2]
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Royal Victorian Eye and Ear Hospital
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Ethics committee address [2]
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32 Gisborne Street
East Melbourne
Victoria 3002 AUSTRALIA
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
244116
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01/07/2009
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Approval date [2]
244116
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10/11/2009
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Ethics approval number [2]
244116
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09/893H
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Ethics committee name [3]
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St. Vincent's Hospital Melbourne - HREC D
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Ethics committee address [3]
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41 Victoria Parade
Fitzroy VIC 3065
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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01/07/2009
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Approval date [3]
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10/11/2009
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Ethics approval number [3]
244117
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096/09
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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.
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Trial website
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Trial related presentations / publications
Celia S Chen 1, AndrewW Lee, Bruce Campbell, Tien Lee, Mark Paine, Clare Fraser, John Grigg, Romesh Markus. Efficacy of intravenous tissue-type plasminogen activator in central retinal artery occlusion: report from a randomized, controlled trial. Stroke
. 2011 Aug;42(8):2229-34. doi: 10.1161/STROKEAHA.111.613653. Epub 2011 Jul 14.
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Celia Chen
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Address
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Flinders Medical Center and Flinders University
South Australia
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Country
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Australia
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Phone
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+61 8 82044252
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Dr. Celia Chen
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Address
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Department of Ophthalmology
Flinders Medical Centre and Flinders University
Bedford Drive, Bedford Park
South Australia 5042
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Country
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Australia
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Phone
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(08) 82044899
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Fax
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(08) 82770899
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Dr. Celia Chen
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Address
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Department of Ophthalmology
Flinders Medical Centre and Flinders University
Bedford Drive, Bedford Park
South Australia 5042
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Country
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Australia
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Phone
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(08) 82044899
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Fax
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(08) 82770899
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Chen CS, Lee AW, Campbell B, Lee T, Paine M, Frase...
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Plain language summary
No
RESULT : 16 patients were randomized. 2/8 (25%) of...
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Documents added automatically
No additional documents have been identified.
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