Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001246471
Ethics application status
Approved
Date submitted
3/08/2016
Date registered
6/09/2016
Date last updated
6/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Platelet Activation in Retinal Vein Occlusion
Scientific title
Platelet Activation in Branch Retinal Vein Occlusion
Secondary ID [1] 289835 0
Nil Known
Universal Trial Number (UTN)
U1111-1186-0205
Trial acronym
BRVO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Branch Retinal Vein Occlusion 299765 0
Condition category
Condition code
Eye 299698 299698 0 0
Diseases / disorders of the eye
Blood 299699 299699 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Months
Description of intervention(s) / exposure
Blood sampled will be collected in patients with acute branch retinal vein occlusion (BRVO). Platellet activation will be assessed. Patients with BRVO will be treated with conventional therapy. Duration of observation is 1 month.
Intervention code [1] 295514 0
Not applicable
Comparator / control treatment
healthy adult subjects serving as controls with no history of systemic or ocular disease. Blood samples are collected once in these participants.
Control group
Active

Outcomes
Primary outcome [1] 299157 0
Mean platelet volume count will be assessed using serum samples.
Timepoint [1] 299157 0
1 month post enrolment. These participants will be followed-up for 1 month
Primary outcome [2] 299158 0
platelet distribution width count will be assessed using serum samples
Timepoint [2] 299158 0
1 month post enrolment. These participants will be followed-up for 1 month
Primary outcome [3] 299159 0
Platelletcrit count will be assessed using serum samples.
Timepoint [3] 299159 0
1 month post enrolment. These participants will be followed-up for 1 month
Secondary outcome [1] 326356 0
None
Timepoint [1] 326356 0
None

Eligibility
Key inclusion criteria
We included the BRVO patients with posterior segment involvement.. The diagnosis of BRVO will reached using funud photography, flourescein angiography, and optical cohrence tomography. Patients and healthy volunteers that were matched for age and gender included in this study
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients and healthy volunteers who were on any kind of medication including corticosteroid and immunosuppressive therapy, who had smoking (smoke more than 1 cigarette per day) and drinking ( >1 standard drink per week) habits, or who had history of systemic and ocular disease will not included in the study

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We require about 60 subjects (30 subjects for BRVO group and 30 subjects for control group). Differences between the two groups for thrombophilic parameters will evaluated using by a t-test according to Bonferroni procedures for multiple comparisons. The level of significance was set at <0.05.

For a study power of 80%, we determined 30 subjects will enough to test all parameters. The power of the test is pathfinder to know the probability that the test will give the right result when there is a real effect. The power of the significance test is the same thing as the sensitivity of a screening test. The effect size was 0.5.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
30/09/2016
Actual
Date of last data collection
Anticipated
31/10/2016
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 8072 0
Turkey
State/province [1] 8072 0

Funding & Sponsors
Funding source category [1] 294215 0
Hospital
Name [1] 294215 0
Ankara Ulucanlar Eye Education and research hospital.
Country [1] 294215 0
Turkey
Primary sponsor type
Hospital
Name
Ankara Ulucanlar Eye Education and research hospital.
Address
Ulucanlar cd. no:59 06230 Altindag/Ankara/Turkey
Country
Turkey
Secondary sponsor category [1] 293048 0
None
Name [1] 293048 0
None
Address [1] 293048 0
None
Country [1] 293048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295624 0
Ankara Numune Training and Research Hospital
Ethics committee address [1] 295624 0
Hacettepe, Talatpasa Blv No:44, 06100 Altindag/Ankara
Ethics committee country [1] 295624 0
Turkey
Date submitted for ethics approval [1] 295624 0
02/05/2016
Approval date [1] 295624 0
16/05/2016
Ethics approval number [1] 295624 0
181204

Summary
Brief summary
Purpose: To search platelet activation via detecting three important platelet activation parameters; Mean Platelet Volume (MPV), Platelet Distribution Width (PDW), and Plateletcrit (PCT) in patients with branch retinal vein occlusion (BRVO) in comparison to those in healthy adults as controls.
Design: A prospective case control study
Participants and Controls: 30 patients within the BRVO (Group 1) and 30 age-and sex-matched healthy controls will included into the study (Group 2).
Methods: All patients and control subjects will undergo complete ophthalmologic evaluation. MPV, PDW, and PCT were measured in the studied groups.
Main Outcome Measures: Alterations in platelet activation parameters.
The mean level of MPV PDW and PCT value in Group 1 and in Group 2 will determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67982 0
Prof Mehmet CITIRIK
Address 67982 0
SB Ankara Ulucanlar Eye Education and Research Hospital.
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 67982 0
Turkey
Phone 67982 0
+903123126261
Fax 67982 0
+903123124827
Email 67982 0
[email protected]
Contact person for public queries
Name 67983 0
Dr Ali Keles
Address 67983 0
SB Ankara Ulucanlar Eye Education and Research Hospital.
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 67983 0
Turkey
Phone 67983 0
+903123126261
Fax 67983 0
+903123124827
Email 67983 0
[email protected]
Contact person for scientific queries
Name 67984 0
Prof Mehmet CITIRIK
Address 67984 0
SB Ankara Ulucanlar Eye Education and Research Hospital.
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 67984 0
Turkey
Phone 67984 0
+903123126261
Fax 67984 0
+903123124827
Email 67984 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBranch retinal vein occlusion associated with platelet activation.2019https://dx.doi.org/10.3906/sag-1807-223
N.B. These documents automatically identified may not have been verified by the study sponsor.