TPE in Rennes Hospital
COMPLASMA
Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018
1 other identifier
observational
190
1 country
1
Brief Summary
To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
Shorter than P25 for all trials
1 active site
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 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedFirst Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedApril 12, 2023
April 1, 2023
15 days
March 14, 2019
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of side effects during Therapeutic plasma exchange
Occurrence of side effects, regardless of their severity during therapeutic plasma exchange sessions (From start of care by the nurse including the preparation for the insertion of peripheral or central venous access to disconnection from the device and removal of peripheral lines or closing the CVC),. Main side effects recorded are hypotension, tachycardia, shock, anaphylaxis, seizure, cardiac arrest, respiratory failure, skin rash, urticaria, catheter dysfunction, catheter related infection hypocalcemia, alkalosis.
The inclusion day (retrospective study)
Interventions
All TPEs were performed by the centrifugation technique using the Fresenius Kabi COMTEC machine
Eligibility Criteria
All adult patients who underwent TPE in Rennes University Hospital 2011-2018
You may qualify if:
- All adult patients who underwent TPE in Rennes University Hospital 2011-2018
You may not qualify if:
- Absence of the monitoring sheet during the EP session
- Refusal of patient participation after receipt of the information letter
- Persons over the age of majority who are subject to legal protection (protection of justice, guardianship, guardianship)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire de Rennes
Rennes, 35033, France
Related Publications (1)
Coirier V, Lesouhaitier M, Reizine F, Painvin B, Quelven Q, Maamar A, Gacouin A, Tadie JM, Le Tulzo Y, Camus C. Tolerance and complications of therapeutic plasma exchange by centrifugation: A single center experience. J Clin Apher. 2022 Feb;37(1):54-64. doi: 10.1002/jca.21950. Epub 2021 Nov 17.
PMID: 34786746DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe CAMUS, MD
Rennes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 25, 2019
Study Start
August 15, 2018
Primary Completion
August 30, 2018
Study Completion
September 30, 2018
Last Updated
April 12, 2023
Record last verified: 2023-04