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Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

Primary Purpose

Thrombosis

Status
Unknown status
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
aspirin
Sponsored by
Tunis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thrombosis focused on measuring vascular access, hemodialysis, aspirin resistance, PFA-100

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Placebo Comparator

No Intervention

Arm Label

aspirn fixed dose

aspirin dose titrated with PFA-100

placebo arm

Arm Description

patients of this arm will receive 100 mg of aspirin daily.over the period of follow up we will detect all thromboembolic events.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 29, 2014
Last Updated
February 3, 2014
Sponsor
Tunis University
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1. Study Identification

Unique Protocol Identification Number
NCT02055131
Brief Title
Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tunis University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
Keywords
vascular access, hemodialysis, aspirin resistance, PFA-100

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aspirn fixed dose
Arm Type
Placebo Comparator
Arm Description
patients of this arm will receive 100 mg of aspirin daily.over the period of follow up we will detect all thromboembolic events.
Arm Title
aspirin dose titrated with PFA-100
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
placebo arm
Arm Type
No Intervention
Arm Description
in this group of patients we will just supervise thromboembolic events of the vascular access.
Intervention Type
Drug
Intervention Name(s)
aspirin
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
incidence and severity of aspirin complications in dialysed patients
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Samir, professor
Official's Role
Study Director
Facility Information:
Facility Name
clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manel Ben Salah, nephrologist
Phone
+216 55 928 869
Email
manell_bs@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sabra Aloui, professor
Phone
+216 92453822
Email
alouisabra@yahoo.fr
First Name & Middle Initial & Last Name & Degree
asma fradi, assistant
First Name & Middle Initial & Last Name & Degree
Manel Ben Salah, nephrologist
First Name & Middle Initial & Last Name & Degree
Sabra Aloui, professor

12. IPD Sharing Statement

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Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis

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