NCT04261205

Brief Summary

A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2020

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2020

Completed
Last Updated

November 16, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

November 27, 2019

Last Update Submit

November 13, 2020

Conditions

Kidney Failure

Keywords

Chronic hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Apheresis by DFPP and biological efficiency

    quantification of the purification carried out (volume)

    over a period of one year

Secondary Outcomes (3)

  • Clinical side effects

    within 1 hour of all session

  • Biological side effects

    within 1 hour of all session

  • variation of Hb, platelet and albumin before and after session

    within 1 hour of all session

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over 18 years of age who consecutively benefit from plasmapheresis sessions by double cascade filtration system during hospitalization at the University Hospital of Nîmes, within the framework of the usual indications retained in the department for a period of 12 months.

You may qualify if:

  • Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes.

You may not qualify if:

  • Under guardianship or curatorship Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes, Hôpital Universitaire Caremeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Olivier Moranne, MD, PhD

    CHU Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

February 7, 2020

Study Start

August 4, 2018

Primary Completion

October 17, 2020

Study Completion

November 13, 2020

Last Updated

November 16, 2020

Record last verified: 2020-10

Locations

FR(1)