Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

February 3, 2014 updated by: Ben Salah Manel, Tunis University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Monastir, Tunisia, 5000
        • Recruiting
        • clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir
        • Contact:
        • Contact:
        • Sub-Investigator:
          • asma fradi, assistant
        • Principal Investigator:
          • Manel Ben Salah, nephrologist
        • Principal Investigator:
          • Sabra Aloui, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
incidence and severity of aspirin complications in dialysed patients
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Nouira Samir, professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

September 1, 2014

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

February 3, 2014

First Posted (ESTIMATE)

February 4, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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