Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02055131
• Other study ID #: 913
• Status: Recruiting
• Phase: Phase 4
• First received: January 29, 2014
• Last updated: February 3, 2014
• Start date: November 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2014
• Source: Tunis University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia:health ministry
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• aspirin

Locations

Country	Name	City	State
Tunisia	clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Tunis University

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence and severity of aspirin complications in dialysed patients		1 year	Yes
Primary	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	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	Yes
Secondary	number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.		1 year	Yes