Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001178437
Ethics application status
Approved
Date submitted
30/06/2016
Date registered
26/08/2016
Date last updated
26/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Platelet Parameters in Behcet's Disease
Scientific title
Platelet Parameters in Ocular Behcet's Disease With Posterior Segment Involvement
Secondary ID [1] 289578 0
Nil known
Universal Trial Number (UTN)
U1111-1184-8290
Trial acronym
Ocular BD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behcet disease 299316 0
Condition category
Condition code
Eye 299309 299309 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 299535 299535 0 0
Other inflammatory or immune system 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 inactive and active stage of Behcet disease. Patients with active disease will be treated with conventional therapy. Duration of observation is 1 month.
Intervention code [1] 295180 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] 298795 0
At least 25 ocular BD patients with posterior segment involvement in the active period.
Mean platelet volume count will be assessed using serum samples.
Timepoint [1] 298795 0
1 month post enrolment. Serum samples collected in active BD patients at 1 month.
Primary outcome [2] 299014 0
platelet distribution width count will be assessed using serum samples.
Timepoint [2] 299014 0
1 month post enrolment. Serum samples collected in active BD patients at 1 month.
Primary outcome [3] 299015 0
Platelletcrit count will be assessed using serum samples.
Timepoint [3] 299015 0
1 month post enrolment. Serum samples collected in active BD patients at 1 month.
Secondary outcome [1] 325233 0
None
Timepoint [1] 325233 0
None

Eligibility
Key inclusion criteria
We included the active ocular Behcet’s disease (BD) patients with posterior segment involvement.. The diagnosis of BD will reached according to the criteria of the International Study Group for Behcet’s Disease. Subjects with at least 2 months of lesion-free period were regarded in the inactive disease period, and subjects with any oral, skin, and/or genital lesions will regarded as in the active disease period. Patients and healthy volunteers that were matched for age and gender included in this study
Minimum age
20 Years
Maximum age
50 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 at least 25 participants per three groups (Active, inactive, control). Differences among the three groups for thrombophilic parameters will evaluated using one-way ANOVA analysis, where applicable. Bonferroni test will used as post hoc test after one-way ANOVA. The level of significance was set at <0.05.

For a study power of 80%, we determined 25 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
1/07/2016
Date of last participant enrolment
Anticipated
31/08/2016
Actual
Date of last data collection
Anticipated
30/09/2016
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 7989 0
Turkey
State/province [1] 7989 0
Turkey

Funding & Sponsors
Funding source category [1] 293966 0
Hospital
Name [1] 293966 0
Ankara Ulucanlar Eye Education and research hospital.
Country [1] 293966 0
Turkey
Primary sponsor type
Hospital
Name
SB Ankara Ulucanlar Eye Education and Research Hospital
Address
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country
Turkey
Secondary sponsor category [1] 292780 0
None
Name [1] 292780 0
None
Address [1] 292780 0
None
Country [1] 292780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295381 0
Ankara Numune Training and Research Hospital
Ethics committee address [1] 295381 0
Hacettepe, Talatpasa Blv No:44, Altindag/Ankara
Ethics committee country [1] 295381 0
Turkey
Date submitted for ethics approval [1] 295381 0
01/04/2016
Approval date [1] 295381 0
15/04/2016
Ethics approval number [1] 295381 0
181175

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 ocular Behcet's disease (BD) in comparison to those in healthy adults as controls.
Design: A prospective case control study
Participants and Controls: Twenty-five patients within the active period of the ocular BD with posterior segment involvement (Group 1), 25 patients within the inactive period of the ocular BD with posterior segment involvement (Group 2) and 25 age-and sex-matched healthy controls will included into the study (Group 3).
Methods: All patients and control subjects will undergo complete ophthalmologic evaluation. MPV, PDW, and PCT will measure in the studied groups.
Main Outcome Measures: Alterations in platelet activation parameters.
Results: The mean level of MPV value in Group 1, in Group 2, and in Group 3 will determined. Mean serum level of PDW in three groups will determined. Mean serum PCT value in Group 1, in Group 2, and in Group 3 will determined. MPV, PDW, and PCT levels can be significantly altered in ocular BD patients.
Conclusion: Platelet activation reflected by MPV, PDW, and PCT may have an impact on the genesis of vessel occlusion in ocular BD with posterior segment involvement. The results may be important for the clinical management of patients with ocular BD in everyday clinical practice since those platelet parameters are routinely detected in complete blood count analyses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67058 0
Prof Mehmet CITIRIK
Address 67058 0
SB Ankara Ulucanlar Eye Education and Research Hospital.
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 67058 0
Turkey
Phone 67058 0
+903123126261
Fax 67058 0
+903123124827
Email 67058 0
[email protected]
Contact person for public queries
Name 67059 0
Dr Ali Keles
Address 67059 0
SB Ankara Ulucanlar Eye Education and Research Hospital.
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 67059 0
Turkey
Phone 67059 0
+903123126261
Fax 67059 0
+903123124827
Email 67059 0
[email protected]
Contact person for scientific queries
Name 67060 0
Prof Mehmet CITIRIK
Address 67060 0
SB Ankara Ulucanlar Eye Education and Research Hospital.
Ulucanlar Cad. No: 59 06230 ALTINDAG/ANKARA/TURKEY
Country 67060 0
Turkey
Phone 67060 0
+903123126261
Fax 67060 0
+903123124827
Email 67060 0
[email protected]

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