Platelet Function in Hemodialysis Patient

Chronic Kidney Disease Clinical Trial

Official title:

Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792283
• Other study ID #: PA15098
• Status: Completed
• Phase: N/A
• First received: June 2, 2016
• Last updated: February 12, 2018
• Start date: January 28, 2016
• Est. completion date: December 29, 2017

Study information

• Verified date: February 2018
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• whole blood collection

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFA-100 quantification		at the day of inclusion