IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES.

Study Overview
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Brief Summary
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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

Detailed Description
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Not provided

Official Title
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IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES.

Conditions
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Therapeutic Plasma Exchange

Intervention / Treatment
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* Diagnostic Test: Evolution of antibodies titre


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 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. Exclusion Criteria: Patients treated with therapeutic plasma exchange for an acute condition at the intensive care unit Patients unable to sign the ICF or unwilling to participate to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Evolution of anti-SARS-CoV-2 titer over time in vaccinated adult patients treated with TPE.<br>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. | Diagnostic Test: Evolution of antibodies titre<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic plasma exchange, anti-SARS-CoV-2 antibodies