Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02055131

Enrollment

300

Registered

2014-02-04

Start date

2013-11-30

Completion date

2015-03-31

Last updated

2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis

Keywords

vascular access, hemodialysis, aspirin resistance, PFA-100

Brief summary

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.

Detailed description

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.

Interventions

DRUGaspirin

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	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

Secondary

Measure	Time frame
number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.	1 year

Other

Measure	Time frame
incidence and severity of aspirin complications in dialysed patients	1 year

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026