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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| placebo arm | No Intervention | in this group of patients we will just supervise thromboembolic events of the vascular access. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin | Drug |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| incidence and severity of aspirin complications in dialysed patients | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nouira Samir, professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir | Recruiting | Monastir | Monastir Governorate | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |