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Clinical Trials/NCT04261205
NCT04261205CompletedNot Applicable

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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country70 target enrollmentStarted: August 4, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Apheresis by DFPP and biological efficiency

Study Overview

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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Apheresis by DFPP and biological efficiency

Time Frame: over a period of one year

quantification of the purification carried out (volume)

Secondary Outcomes

  • variation of Hb, platelet and albumin before and after session(within 1 hour of all session)
  • Biological side effects(within 1 hour of all session)
  • Clinical side effects(within 1 hour of all session)

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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