Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis
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|ClinicalTrials.gov Identifier: NCT02055131|
Recruitment Status : Unknown
Verified February 2014 by Ben Salah Manel, Tunis University.
Recruitment status was: Recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis||Drug: aspirin||Phase 4|
Three groups of dialysed patients will be included in this study. The first is the placebo group, the second is the aspirin group fixed dose and the last group includes patients receiving a dose of aspirin titrated by the result of PFA-100.
At the end of this study the investigators will be able to identify whether systematic antiaggregation is suitable for a vascular access for hemodialysis. The investigators will also conclude which is better for patients fixed dose or aspirin dose escalation determined by the result of PFA-100. The study will analyse the prevalence of aspirin resistant patients in this particular population of dialysed patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||a Comparative Study of Aspirin Either at Fixed Dose or at a Dose Titrated by Platlet Function Analyzer(PFA-100) vs Placebo in Primary Prevention of Vascular Access for Hemodialysis|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||March 2015|
Placebo Comparator: aspirn fixed dose
patients of this arm will receive 100 mg of aspirin daily.over the period of follow up we will detect all thromboembolic events.
Placebo Comparator: aspirin dose titrated with PFA-100
patients of this arm will receive 100 mg of aspirin daily.this dose will be multiplied whenever the PFA-100 is not suitable.once the time of occlusion is correct ,we will keep the same dose of aspirin and continue monitoring the PFA-100 durin the follow up period.
No Intervention: placebo arm
in this group of patients we will just supervise thromboembolic events of the vascular access.
- number of fistula thrombosis in patients receiving a dose of aspirin titrated by the result of PFA-100 compared to placebo and fixed dose aspirin [ Time Frame: 1 year ]patients undergoing hemodialysis via native fistula will receive either placebo or aspirin titrated dose by the PFA-100 or aspirin fixed dose to prevent thrombosis of the access .the follow up period will be fixed at 1 year and all thromboembolic complications of the access will be noted
- number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients. [ Time Frame: 1 year ]
- incidence and severity of aspirin complications in dialysed patients [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055131
|clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir||Recruiting|
|Monastir, Tunisia, 5000|
|Contact: Manel Ben Salah, nephrologist +216 55 928 869 firstname.lastname@example.org|
|Contact: Sabra Aloui, professor +216 92453822 email@example.com|
|Sub-Investigator: asma fradi, assistant|
|Principal Investigator: Manel Ben Salah, nephrologist|
|Principal Investigator: Sabra Aloui, professor|
|Study Director:||Nouira Samir, professor|