Arterio-venous Fistula, Puncture, Chronic DeseaseNCT03355508
Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
A study testing pucture in the arteriovenous fistula in people with Arterio-venous Fistula, Puncture, Chronic Desease, run by Poissy-Saint Germain Hospital at 1 site in France.
Trial summary
40000 patients are hemodialysis each year in France . In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible: Bevel puncture upwards then flipping the needle or puncture bevel down. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterio-venous Fistula, Puncture, Chronic Desease
- What is being tested?
- pucture in the arteriovenous fistula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2017to Feb 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient in chronic renal failure treated by hemodialysis with native arteriovenous fistula as a vascular approach.
- Adult of age and sex indifferent.
- Normal puncture of the fistula with two needles (bipuncture).
- Fistula use for more than 3 months.
- Beneficiary of Medicare or State Medical Aid.
- No opposition to participation in the study.
Who cannot join
- Patient who does not speak and does not understand French.
- Hemodialysis patient awaiting a transplant by a living donor.
- Patient with more than 2 AVF dilatations in the last 6 months.
- Patient with prosthetic arteriovenous fistula.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CH Poissy st Germain
Poissy
Loizeau Valerie
About this study
40000 patients are hemodialysis each year in France .
In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:
- Bevel puncture upwards then flipping the needle
- or puncture bevel down. At present, there is no consensus or study on the technique of puncture fistula which generates different professional practices.
- Being tested
- pucture in the arteriovenous fistula
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pucture in the arteriovenous fistulaDevice
The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute.
An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up.
We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average.
A draw will determine for each patient the order in which the direction of the needles will be used.
After this determination of the reference time, the patient will enter two successive phases where it will be punctured bevel up (phase 2) and then down (phase 3) or vice versa following the draw.
| Study group | Role | What they receive |
|---|---|---|
| puncture bevel up | Other | Not described Receives: Device: pucture in the arteriovenous fistula |
| puncture bevel domn | Other | Not described Receives: Device: pucture in the arteriovenous fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compression time required for hemostasis
The primary endpoint is the compression time required for hemostasis after needle removal, which is stable over a 3-week period.
The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute. An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up. We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average. A draw will determine for each patient the order in which the direction of the needles will be used. After this determination of the reference time, the patient will enter two successive phases where it will be tapped bevel up (phase 2) and then down (phase 3) or vice versa following the draw.
Measured: period of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start29 Sep 2017
- Primary completionSep 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterio-venous Fistula, Puncture, Chronic DeseaseStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valérie LOIZEAU, Poissy-Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355508
- Sponsor's protocol ID
- TECHFAVHEMO
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver
- ClinicalTrials.gov ID
- NCT03355508
- Acronym / sponsor ID
- TECHFAVHEMO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 28 Nov 2017 (actual)
- 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.
40000 patients are hemodialysis each year in France .
In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:
- Bevel puncture upwards then flipping the needle
- or puncture bevel down. At present, there is no consensus or study on the technique of puncture fistula which generates different professional practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| puncture bevel up | Other | Device: pucture in the arteriovenous fistula |
| puncture bevel domn | Other | Device: pucture in the arteriovenous fistula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient in chronic renal failure treated by hemodialysis with native arteriovenous fistula as a vascular approach.
- Adult of age and sex indifferent.
- Normal puncture of the fistula with two needles (bipuncture).
- Fistula use for more than 3 months.
- Beneficiary of Medicare or State Medical Aid.
Key exclusion criteria (4 listed)
- Patient who does not speak and does not understand French.
- Hemodialysis patient awaiting a transplant by a living donor.
- Patient with more than 2 AVF dilatations in the last 6 months.
- Patient with prosthetic arteriovenous fistula.
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 |
|---|---|---|
| pucture in the arteriovenous fistulaThe compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute. An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up. We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average. A draw will determine for each patient the order in which the direction of the needles will be used. After this determination of the reference time, the patient will enter two successive phases where it will be punctured bevel up (phase 2) and then down (phase 3) or vice versa following the draw. | Device | puncture bevel domn, puncture bevel up |
Primary outcome
Compression time required for hemostasis
Time frame: period of 3 weeks
The primary endpoint is the compression time required for hemostasis after needle removal, which is stable over a 3-week period. The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute. An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up. We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average. A draw will determine for each patient the order in which the direction of the needles will be used. After this determination of the reference time, the patient will enter two successive phases where it will be tapped bevel up (phase 2) and then down (phase 3) or vice versa following the draw.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pucture in the arteriovenous fistula in people with Arterio-venous Fistula, Puncture, Chronic Desease, run by Poissy-Saint Germain Hospital at 1 site in France.
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 6 inclusion and 4 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 28 Nov 2017. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Loizeau Valerie (0139274727, vloizeau@chi-poissy-st-germain.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compression time required for hemostasis (time frame: period of 3 weeks). 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 28 Nov 2017.