TPE in Rennes Hospital

Therapeutic Plasma Exchange Clinical Trial

— COMPLASMA  

Official title:

Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888417
• Other study ID #: 35RC16_3049_COMPLASMA
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: April 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years

Description:

Indications were recorded from the patients electronic chart. Side effects were identified from the review of TPE monitoring forms completed prospectively by the nurse who performed the TPE during the course of the procedure

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients who underwent TPE in Rennes University Hospital 2011-2018

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Therapeutic Plasma Exchange

Intervention

Device:
• Therapeutic plasma exchange (TPE)
All TPEs were performed by the centrifugation technique using the Fresenius Kabi COMTEC machine

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)