Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

aspirin

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

aspirin

Intervention Type DRUG

placebo arm

in this group of patients we will just supervise thromboembolic events of the vascular access.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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aspirin

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No