ThrombosisPhase 4NCT02055131
Antiaggregation in Primary Prevention of Vascular Access for Hemodialysis
A Phase 4 study testing aspirin in people with Thrombosis, run by Tunis University at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombosis
- What is being tested?
- aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- Nov 2013to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- dialysed patients
- vascular access aged less than one year
- no serious complication of the vascular access previously such as hemorrhagic complication and tight stenosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir
Monastir, Monastir Governorate, 5000
Manel Ben Salah, nephrologist, +216 55 928 869, manell_bs@hotmail.com
Sabra Aloui, professor, +216 92453822, alouisabra@yahoo.fr
About this study
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
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.
Read the 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.
- Conditions
- Thrombosis
- Being tested
- aspirin
- Keywords
- vascular access, hemodialysis, aspirin resistance, PFA-100
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: aspirin |
| placebo arm | No intervention | in this group of patients we will just supervise thromboembolic events of the vascular access. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionSep 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Salah Manel, Tunis University
- Investigators
- Nouira Samir, professor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055131
- Sponsor's protocol ID
- 913
- Status last verified
- Feb 2014
- First submitted
- 29 Jan 2014
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02055131
- Acronym / sponsor ID
- 913
- Conditions
- Thrombosis
- Keywords
- vascular access, hemodialysis, aspirin resistance, PFA-100
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aspirn fixed dose | Placebo comparator | Drug: aspirinpatients 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 | Drug: aspirinpatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- dialysed patients
- vascular access aged less than one year
- no serious complication of the vascular access previously such as hemorrhagic complication and tight stenosis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin | Drug | aspirin dose titrated with PFA-100, aspirn fixed dose |
Primary outcome
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 secondary outcome
number of aspirin resistant patients even to aspirin escalation dose titrated by PFA-100 in the population of dialysed patients.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
clinical and medical investigation in emergency medecine laboratry,hospitalo-university center of Monastir
Monastir, Tunisia
Nouira Samir, professor study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin in people with Thrombosis, run by Tunis University at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.