Status:
COMPLETED
Algorithm for Apherisis Monitoring and Prescription Assistance in Sickle Cell Patients (ALGODREP)
Lead Sponsor:
Etablissement Français du Sang
Collaborating Sponsors:
Assistance Publique - Hôpitaux de Paris
Paris 12 Val de Marne University
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of this study is to prove the superiority of a procedure which calculates the volume of RBCs to transfuse and the time between apheresis based on this algorithm, compared to the cur...
Detailed Description
Sickle cell disease (SCD) is the most common genetic disease leading to abnormal hemoglobin (HbS). Chronic complications can be severe and affect multiple organs. Among them, cerebrovascular disease i...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Have sickle cell disease, defined as those individuals with HbSS or HbSβ0Thal
- Included in a Blood Exchange Transfusion program (apherisis)
- Benefiting from social insurance
- Accepting to participate in the study and having signed the informed consent
Exclusion
- Have sickle cell disease defined with S-β+thal
- Receiving EPO treatment
- Pregnant or breast-feeding women
- Lack of effective contraception in women in childbearing age
- Patient under guardianship
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04076683
Start Date
January 5 2022
End Date
November 30 2023
Last Update
January 26 2024
Active Locations (8)
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1
EFS Rhône-Alpes-Auvergne
Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France, 42277
2
Centre de Santé EFS
Besançon, Bourgogne-Franche-Comté, France, 25000
3
Centre de Santé EFS
Rennes, Brittany Region, France, 35016
4
Centre de Santé EFS
Tours, Centre-Val de Loire, France, 37206