Sponsor study identifier
interventional
15
1 country
1
Study Start
September 8, 2021
Actual (reported)Primary Completion
February 1, 2022
Actual (reported)Study Completion
February 1, 2022
Actual (reported)Context: Therapeutic plasma exchange is an extracorporeal blood purification technique that removes pathogenic substances (including antibodies) from plasma. This technique also combines an immunomodulatory effect. The impact on the anti-SARS-CoV-2 titre and the humoral and cellular responses in the general population benefiting from therapeutic plasma exchanges is not known at this time. The purpose of this study is to evaluate the evolution of anti-SARS-CoV-2 antibodies' titre over time in vaccinated adult patients treated with therapeutic plasma exchange. Research question and associated variables: Prospective non-drug interventional study on the possible variation of anti-SARS-CoV-2 antibody titre in adult patients regularly treated with therapeutic plasma exchange. Study population: any adult patient vaccinated against SARS-CoV-2 (any type of vaccine) and regularly receiving therapeutic plasma exchange in the adult hematology department of the Cliniques universitaires Saint Luc in Brussels, Belgium. Number of subjects expected to be enrolled: 10-15
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 8, 2021
Actual (reported)December 30, 2021
Actual (reported)January 13, 2022
Actual (reported)February 1, 2022
Actual (reported)February 1, 2022
Actual (reported)Analysis of the variation of the anti-SARS-CoV-2 antibodies with plasma exchange procedures
Evolution of anti-SARS-CoV-2 antibodies titre over time in vaccinated adult patients treated with TPE.
3 months
Assessment of the possible variation of anti-SARS-CoV-2 antibody titer in adult patients regularly treated with therapeutic plasma exchange. For each patient included in this study, 3 blood samples of 5 ml(serum) will be collected at well-defined time points: at the beginning of an TPE session, at the end of the same session, and at the beginning of the consecutive TPE session.
For each patient included in this study, 3 blood samples of 5 ml(serum) will be collected at well-defined time points: at the beginning of an TPE session, at the end of the same session, and at the beginning of the consecutive TPE session.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cliniques universitaires Saint-Luc
Brussels, International, 1200, Belgium
Catherine Lambert, Pr
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
15 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2021
First Posted
January 13, 2022
Study Start
September 8, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 1, 2022
Actual (reported)Study Completion
February 1, 2022
Actual (reported)Last Updated
November 8, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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