Platelet Function in Hemodialysis Patient
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
whole blood collection
Sponsored by
About this trial
This is an interventional screening trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion criteria :
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
Exclusion criteria :
pregnancy, breast feeding legal guardianchip hemodialysis on a catheter inability to sign the consent
Sites / Locations
- Chu Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients undergoing hemodialysis
Arm Description
Outcomes
Primary Outcome Measures
PFA-100 quantification
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02792283
Brief Title
Platelet Function in Hemodialysis Patient
Official Title
Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 28, 2016 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
December 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients undergoing hemodialysis
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
whole blood collection
Primary Outcome Measure Information:
Title
PFA-100 quantification
Time Frame
at the day of inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
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
Exclusion criteria :
pregnancy, breast feeding legal guardianchip hemodialysis on a catheter inability to sign the consent
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Platelet Function in Hemodialysis Patient
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