Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

Kidney Failure Clinical Trial

— DFPPSURV  

Official title:

Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261205
• Other study ID #: Local/2017/0M-01
• Status: Completed
• Start date: August 4, 2018
• Est. completion date: November 13, 2020

Study information

• Verified date: October 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The objective of the study is to conduct a prospective evaluation of the practice of apheresis by Double Filtration System Cascade system in a university centre in current practice with evaluation of the technical and biological effectiveness as the main objective and clinical and biological tolerance as the secondary objective for all consecutive sessions performed in a university centre over a period of 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 13, 2020
• Est. primary completion date: October 17, 2020
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

Over 18 years of age I indication for plasmapheresis and hospitalized at Chu de Nimes. Exclusion Criteria: Under guardianship or curatorship Refusal to participate

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Locations

Country	Name	City	State
France	CHU de Nîmes, Hôpital Universitaire Caremeau	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apheresis by DFPP and biological efficiency	quantification of the purification carried out (volume)	over a period of one year
Secondary	Clinical side effects	catheter dysfunction	within 1 hour of all session
Secondary	Biological side effects	Bleeding rate	within 1 hour of all session
Secondary	variation of Hb, platelet and albumin before and after session	% of Hb, platelet and albumin	within 1 hour of all session