Therapeutic Plasma ExchangeCOMPLASMANCT03888417
TPE in Rennes Hospital
An observational study of Therapeutic Plasma Exchange, run by Rennes University Hospital at 1 site in France.
Trial summary
To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapeutic Plasma Exchange
- What is being tested?
- Therapeutic plasma exchange (TPE)
- Type of treatment
- Medical device
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- 15 Aug 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients who underwent TPE in Rennes University Hospital 2011-2018
Who may be able to join
- All adult patients who underwent TPE in Rennes University Hospital 2011-2018
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018
To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years
Read the 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
- Conditions
- Therapeutic Plasma Exchange
- Being tested
- Therapeutic plasma exchange (TPE)
- Keywords
- TPE, therapeutic plasma exchange, Side Effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic plasma exchange (TPE)Device
All TPEs were performed by the centrifugation technique using the Fresenius Kabi COMTEC machine
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The inclusion day (retrospective study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start15 Aug 2018
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic Plasma ExchangeStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe CAMUS, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888417
- Sponsor's protocol ID
- 35RC16_3049_COMPLASMA
- Acronym
- COMPLASMA
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34786746
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018
- ClinicalTrials.gov ID
- NCT03888417
- Acronym / sponsor ID
- COMPLASMA / 35RC16_3049_COMPLASMA
- Conditions
- Therapeutic Plasma Exchange
- Keywords
- TPE, therapeutic plasma exchange, Side Effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients who underwent TPE in Rennes University Hospital 2011-2018
Key inclusion criteria (1 listed)
- All adult patients who underwent TPE in Rennes University Hospital 2011-2018
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic plasma exchange (TPE)All TPEs were performed by the centrifugation technique using the Fresenius Kabi COMTEC machine | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 34786746Coirier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe CAMUS, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Plasma Exchange, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of side effects during Therapeutic plasma exchange (time frame: The inclusion day (retrospective study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.