Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

Sponsor

Tunis University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02055131

Collaborator

(none)

300

Enrollment

Location

Arms

15.9

Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombosis	Drug: aspirin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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 :

Nov 1, 2013

Anticipated Primary Completion Date :

Sep 1, 2014

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: aspirin
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.	Drug: aspirin
No Intervention: placebo arm in this group of patients we will just supervise thromboembolic events of the vascular access.

Arm

Intervention/Treatment

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.

Drug: aspirin

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.

Drug: aspirin

No Intervention: placebo arm

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Other Outcome Measures

incidence and severity of aspirin complications in dialysed patients [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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