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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05191394
Other study ID # 2021/08SEP/367
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2021
Est. completion date February 1, 2022

Study information

Verified date November 2022
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Not provided


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date February 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Evolution of antibodies titre
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.

Locations

Country Name City State
Belgium Cliniques universitaires Saint-Luc Bruxelles International

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT04351438 - Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation
Active, not recruiting NCT03888417 - TPE in Rennes Hospital