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Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02055131
Recruitment Status : Unknown
Verified February 2014 by Ben Salah Manel, Tunis University.
Recruitment status was:  Recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Information provided by (Responsible Party):
Ben Salah Manel, Tunis University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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.

Primary Outcome Measures :
  1. 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

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

Other Outcome Measures:
  1. incidence and severity of aspirin complications in dialysed patients [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02055131

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clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir Recruiting
Monastir, Tunisia, 5000
Contact: Manel Ben Salah, nephrologist    +216 55 928 869   
Contact: Sabra Aloui, professor    +216 92453822   
Sub-Investigator: asma fradi, assistant         
Principal Investigator: Manel Ben Salah, nephrologist         
Principal Investigator: Sabra Aloui, professor         
Sponsors and Collaborators
Tunis University
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Study Director: Nouira Samir, professor
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Responsible Party: Ben Salah Manel, nephrologist, Tunis University Identifier: NCT02055131    
Other Study ID Numbers: 913
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Keywords provided by Ben Salah Manel, Tunis University:
vascular access
aspirin resistance
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors