Chronic Kidney DiseaseNCT02792283
Platelet Function in Hemodialysis Patient
A study testing whole blood collection in people with Chronic Kidney Disease, run by CHU de Reims at 1 site in France.
Trial summary
The objective is to evaluate the function of the platelet in patients undergoing hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood assay with three pathways of platelet activation to describe a platelet response profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- whole blood collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2016to 29 Dec 2017
- 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 with end-stage chronic kidney disease undergoing hemodialysis age ≥ 18 years old hemodialysis on a peripheral vascular access (arteriovenous fistula or graft) hematocrit between 0.35 and 0.50 and platelet count between 150 and 500 G/L written consent after oral and written information
Who cannot join
- pregnancy, breast feeding legal guardianchip hemodialysis on a catheter inability to sign the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®
The objective is to evaluate the function of the platelet in patients undergoing hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood assay with three pathways of platelet activation to describe a platelet response profile.
The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to anticoagulate the hemodialyzer, on platelet function will be assessed.
Read the detailed description
The aim of this study is to evaluate the platelet function during hemodialysis. One hundred patients with end-stage renal disease undergoing hemodialysis (2 to 3 sessions per week, 3 to 4 hours per session) will be included.
Patients who meet the inclusion criteria will be included after oral and written information and signature of written consent.
The study consists in recording clinical and biological and the evaluation of platelet function by the PFA-100 assay. This is a whole blood platelet function assay, with 3 pathways of platelet activation (collagen-epinephrine, collagen-ADP and specific P2Y cartridge - Innovance®).
Whole blood is collected in the arterial line of the arteriovenous vascular access (fistula or graft) before and after the hemodialysis session.
PFA-100 is assayed within 2 hours after blood collection and the platelet response profile is interpreted according to the manufacturers instructions.
Clinical informations, especially hemorragic and thrombotic history, are collected the day of inclusion and 6 months after inclusion.
- Conditions
- Chronic Kidney Disease
- Being tested
- whole blood collection
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole blood collectionBiological
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing hemodialysis | Experimental | Not described Receives: Biological: whole blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFA-100 quantification
Measured: at the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start28 Jan 2016
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792283
- Sponsor's protocol ID
- PA15098
- Status last verified
- Feb 2018
- First submitted
- 2 Jun 2016
- Last updated
- 14 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®
- ClinicalTrials.gov ID
- NCT02792283
- Acronym / sponsor ID
- PA15098
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 7 Jun 2016 (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.
The objective is to evaluate the function of the platelet in patients undergoing hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood assay with three pathways of platelet activation to describe a platelet response profile.
The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to anticoagulate the hemodialyzer, on platelet function will be assessed.
Detailed description
The aim of this study is to evaluate the platelet function during hemodialysis. One hundred patients with end-stage renal disease undergoing hemodialysis (2 to 3 sessions per week, 3 to 4 hours per session) will be included.
Patients who meet the inclusion criteria will be included after oral and written information and signature of written consent.
The study consists in recording clinical and biological and the evaluation of platelet function by the PFA-100 assay. This is a whole blood platelet function assay, with 3 pathways of platelet activation (collagen-epinephrine, collagen-ADP and specific P2Y cartridge - Innovance®).
Whole blood is collected in the arterial line of the arteriovenous vascular access (fistula or graft) before and after the hemodialysis session.
PFA-100 is assayed within 2 hours after blood collection and the platelet response profile is interpreted according to the manufacturers instructions.
Clinical informations, especially hemorragic and thrombotic history, are collected the day of inclusion and 6 months after inclusion.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing hemodialysis | Experimental | Biological: whole blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient with end-stage chronic kidney disease undergoing hemodialysis age ≥ 18 years old hemodialysis on a peripheral vascular access (arteriovenous fistula or graft) hematocrit between 0.35 and 0.50 and platelet count between 150 and 500 G/L written consent after oral and written information
Key exclusion criteria (1 listed)
- pregnancy, breast feeding legal guardianchip hemodialysis on a catheter inability to sign the consent
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 |
|---|---|---|
| whole blood collection | Biological | patients undergoing hemodialysis |
Primary outcome
PFA-100 quantification
Time frame: at the day of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole blood collection in people with Chronic Kidney Disease, run by CHU de Reims 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFA-100 quantification (time frame: at the day of inclusion). 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 14 Feb 2018; AzTrials last refreshed its copy on 3 Nov 2026.