Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

• ClinicalTrials.gov Identifier: NCT02055131
• Recruitment Status: Unknown
• First Posted: February 4, 2014
• Last Update Posted: February 4, 2014
• Sponsor: Tunis University
• Information provided by (Responsible Party): Ben Salah Manel, Tunis University

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 (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

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.

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Tunisia

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 manell_bs@hotmail.com

Contact: Sabra Aloui, professor +216 92453822 alouisabra@yahoo.fr

Sub-Investigator: asma fradi, assistant

Principal Investigator: Manel Ben Salah, nephrologist

Principal Investigator: Sabra Aloui, professor

Sponsors and Collaborators

Tunis University

Investigators

• Study Director: Nouira Samir, professor

More Information

• Responsible Party: Ben Salah Manel, nephrologist, Tunis University
• ClinicalTrials.gov Identifier: NCT02055131
• Other Study ID Numbers: 913
• First Posted: February 4, 2014
• Last Update Posted: February 4, 2014
• Last Verified: February 2014

Keywords provided by Ben Salah Manel, Tunis University:

vascular access; hemodialysis; aspirin resistance; PFA-100

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Aspirin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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; Antipyretics