COMPLASMA: TPE in Rennes Hospital

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03888417
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Anticipated Duration (Months): 12.5
• Patients Per Site Per Month: 15.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Therapeutic Plasma Exchange	Device: Therapeutic plasma exchange (TPE)

Detailed 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

Study Design

• Study Type: Observational
• Actual Enrollment: 190 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018
• Actual Study Start Date: Aug 15, 2018
• Actual Primary Completion Date: Aug 30, 2018
• Anticipated Study Completion Date: Aug 30, 2019

Outcome Measures

Primary Outcome Measures

1. Frequency of side effects during Therapeutic plasma exchange [The inclusion day (retrospective study)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Rennes	Rennes		France	35033

Sponsors and Collaborators

• Rennes University Hospital

Investigators

• Principal Investigator: Christophe CAMUS, MD, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT03888417
• Other Study ID Numbers: 35RC16_3049_COMPLASMA
• First Posted: Mar 25, 2019
• Last Update Posted: Mar 25, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rennes University Hospital: TPE; therapeutic plasma exchange; Side Effects

Study Results

No Results Posted as of Mar 25, 2019