NCT04076683Completed
Algorithm for Apherisis Monitoring and Prescription Assistance in Sickle Cell Patients (ALGODREP)
Validation d'Une Stratégie de Programme Transfusionnel Par Erythraphérèse basée Sur un Algorithme d'Aide à la Prescription Transfusionnelle Chez Les Patients Adultes Drépanocytaires
Source: ClinicalTrials.gov · Last updated 26 Jan 2024
Brief summary (registry, in English)
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 current procedure. The primary endpoint would be the number of patients with individually achieved objectives in terms of % HbS before each apheresis (which reflects the effectiveness of the previous apheresis) over a period of 12 months. The secondary objectives would be to compare the volume differences of transfused RBCs in both groups over a period of 12 months, the occurrence of clinical events and the satisfaction of patients and physicians. The investigators hope that this study would improve the efficiency and the performance of apheresis in sickle cell patients. The investigators also hope to facilitate the organization of procedures with the flexibility that would allow the use of this algorithm.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 65 (actual)
- First submitted
- 26 Aug 2019
- Start date
- 5 Jan 2022
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Etablissement Français du Sang
- Diseases
- Sickle cell disease
- NCT number
- NCT04076683
What you commit to
- Study type: Interventional
- Participants enrolled: 65
- From 5 Jan 2022 to the primary completion date, 30 Nov 2023
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving EPO treatment
Other illness
- Have sickle cell disease defined with S-β+thal
Age
- Lack of effective contraception in women in childbearing age
Other
- Pregnant or breast-feeding women
- Patient under guardianship
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Santé EFS Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Centre de Santé EFS Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hopital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| CHU Kremlin Bicêtre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Unknown status |
| Centre de Santé EFS Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| EFS Rhône-Alpes-Auvergne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
| Centre de Santé EFS Coordinator of this site? Confirm its status | Tours | France | Unknown status |
| CHU de Martinique Coordinator of this site? Confirm its status | Le Lamentin | Martinique | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.