- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02055131
Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis
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 Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Monastir, Tunisia, 5000
- Recruiting
- clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir
-
Contact:
- Manel Ben Salah, nephrologist
- Phone Number: +216 55 928 869
- Email: manell_bs@hotmail.com
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Contact:
- Sabra Aloui, professor
- Phone Number: +216 92453822
- Email: alouisabra@yahoo.fr
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Sub-Investigator:
- asma fradi, assistant
-
Principal Investigator:
- Manel Ben Salah, nephrologist
-
Principal Investigator:
- Sabra Aloui, professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
|
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.
|
|
NO_INTERVENTION: placebo arm
in this group of patients we will just supervise thromboembolic events of the vascular access.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.
Time Frame: 1 year
|
1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence and severity of aspirin complications in dialysed patients
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nouira Samir, professor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Thrombosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 913
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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