Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

NCT02055131 | Unknown Phase 4 DMC

• 1 other identifier: 913
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis

Keywords

vascular access; hemodialysis; aspirin resistance; PFA-100

Outcome Measures

Primary Outcomes (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

  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 Outcomes (1)

• number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.

  1 year

Other Outcomes (1)

• incidence and severity of aspirin complications in dialysed patients

  1 year

Study Arms (3)

aspirn fixed dose

PLACEBO COMPARATOR

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

aspirin dose titrated with PFA-100

PLACEBO COMPARATOR

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

placebo arm

NO INTERVENTION

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

Interventions

aspirin DRUG

aspirin dose titrated with PFA-100; aspirn fixed dose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• dialysed patients
• vascular access aged less than one year
• no serious complication of the vascular access previously such as hemorrhagic complication and tight stenosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir

Monastir, Monastir Governorate, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nouira Samir, professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nephrologist

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: February 4, 2014
• Study Start: November 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

TU (1)