Platelet Function in Hemodialysis Patient

Sponsor
CHU de Reims (Other)
Overall Status
Completed
CT.gov ID
NCT02792283
Collaborator
(none)
100
1
1
23
4.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: whole blood collection
N/A

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

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®
Actual Study Start Date :
Jan 28, 2016
Actual Primary Completion Date :
Dec 29, 2017
Actual Study Completion Date :
Dec 29, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: patients undergoing hemodialysis

Biological: whole blood collection

Outcome Measures

Primary Outcome Measures

  1. PFA-100 quantification [at the day of inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Reims Reims France 51092

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT02792283
Other Study ID Numbers:
  • PA15098
First Posted:
Jun 7, 2016
Last Update Posted:
Feb 14, 2018
Last Verified:
Feb 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2018