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OpenTrials
Completed

NCT Number: NCT03888417

TPE in Rennes Hospital

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

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Key information

Conditions

Therapeutic Plasma Exchange

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Therapeutic Plasma Exchange (TPE)

Device

All TPEs were performed by the centrifugation technique using the Fresenius Kabi COMTEC machine

Primary outcomes

  1. Frequency of side effects during Therapeutic plasma exchange

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: COMPLASMA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2019
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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