Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

Phase 4UnknownNCT02055131

Tunis University300 enrolled

Overview

This is a prospective study consisting in testing whether systematic use of aspirin is beneficial for primary prevention of vascular access for hemodialysis attested by doppler ultrasound exam. The investigators will study aspirin resistance in the population of patients undergoing hemodialysis. The investigators will test sensibility of resistant patients to aspirin dose escalation. PFA-100 is the biologic test used in this study to define aspirin resistance.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

300

Conditions

Thrombosis

Interventions

aspirinDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * dialysed patients * vascular access aged less than one year * no serious complication of the vascular access previously such as hemorrhagic complication and tight stenosis Exclusion Criteria: * pregnant and breastfeeding women * patients receiving at baseline other antiaggregant or anticoagulant * patient not allowed to be treated by aspirin * systolic blood pressure\> 200 mmhg * diastolic blood pressure\>115 mmhg * liver failure

Locations (1)

clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir

Monastir, Monastir Governorate, Tunisia

RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: 1 year

Secondary Outcomes

number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.