NCT02792283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

June 2, 2016

Last Update Submit

February 12, 2018

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • PFA-100 quantification

    at the day of inclusion

Study Arms (1)

patients undergoing hemodialysis

EXPERIMENTAL
Biological: whole blood collection

Interventions

whole blood collectionBIOLOGICAL
patients undergoing hemodialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy, breast feeding legal guardianchip hemodialysis on a catheter inability to sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 7, 2016

Study Start

January 28, 2016

Primary Completion

December 29, 2017

Study Completion

December 29, 2017

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

FR(1)