Algorithm for Apherisis Monitoring and Prescription Assistance in Sickle Cell Patients (ALGODREP) (ALGODREP)
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| ClinicalTrials.gov Identifier: NCT04076683 |
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Recruitment Status : Unknown
Verified August 2019 by Etablissement Français du Sang.
Recruitment status was: Not yet recruiting
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sickle Cell Disease | Device: Algodrep | Not Applicable |
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 is one of the most serious leading to a high risk of stroke. These complications often require blood exchange transfusions (BET) in order to replace red blood cells (RBC) containing HbS (from patients) by GR containing HbA (blood donors), and thereby stop the harmful pathophysiological cascade. The indications of long-term apheresis are mostly, but not exclusively, represented by cerebral vasculopathy (85% in our center), and chronic organ damages. Long-term BET in cerebral vasculopathy may considerably reduce the risk of stroke while stopping them leads to a recurrence of this risk, hence there is a need to do them regularly (on average every 4 to 6 weeks) with an objective of HbS ≤ 30%. This objective may be less stringent in the case of other indications.
Two methods are used: a manual method which is feasible anywhere and the apheresis which is preferred because of its better efficacy in achieving the targets of HbS percentage. It also limits transfusion hemochromatosis.
The volume required for BET by apheresis as well as the optimal period between apheresis sessions are empirically determined.
In our practice, the investigators noticed that this method did not allow to steadily obtaining the %HbS objective and the interval between apheresis was variable, in part conditioned by the availability of machines. This implies a real risk of occurrence of recurrent stroke in patients with cerebral vascular disease and may cause a lack of flexibility in the timing of appointments.
Thereby the principal investigator and the biostatistician created an algorithm to compute the volume of blood to be transfused and the interval between apheresis which are necessary to maintain an individual objective of HbS percentage. This algorithm has been obtained by statistical analysis of apheresis performed at Henri Mondor Hospital over a period of 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 65 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Supportive Care |
| Official Title: | Validation d'Une Stratégie de Programme Transfusionnel Par Erythraphérèse basée Sur un Algorithme d'Aide à la Prescription Transfusionnelle Chez Les Patients Adultes Drépanocytaires |
| Estimated Study Start Date : | November 2019 |
| Estimated Primary Completion Date : | November 2020 |
| Estimated Study Completion Date : | November 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Algorithm (arm A)
Frequency and volume for apherisis proposed by algorithm and validated by the physician
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Device: Algodrep
Algorithm computing the volume of blood to be transfused and the interval between apheresis which are necessary to maintain an individual objective of HbS percentage. |
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No Intervention: Usual care (arm C)
Frequency and volume for apherisis only decided by the physician (usual care)
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- Number of patients with individually achieved objectives in terms of % HbS [ Time Frame: For each apherisis over a 12 months period ]
- Volume of transfused RBCs [ Time Frame: For each apherisis over a 12 months period ]
- Number of transfused RBCs [ Time Frame: For each apherisis over a 12 months period ]
- Number of apherisis per participant [ Time Frame: Over a 12 months period ]
- Hematocrit (percentage) [ Time Frame: For each apherisis over a 12 months period ]
- Hemoglobin (g/dL) [ Time Frame: For each apherisis over a 12 months period ]
- Number of reticulocyte (g/L), [ Time Frame: For each apherisis over a 12 months period ]
- Percentage of reticulocyte [ Time Frame: For each apherisis over a 12 months period ]
- Lactate dehydrogenase (UI/L) [ Time Frame: For each apherisis over a 12 months period ]
- Creatinine (mg/L) [ Time Frame: For each apherisis over a 12 months period ]
- Alanine aminotransferase (UI/L) [ Time Frame: For each apherisis over a 12 months period ]
- Aspartate aminotransferase (UI/L) [ Time Frame: For each apherisis over a 12 months period ]
- Bilirubin T (mg/dL) [ Time Frame: For each apherisis over a 12 months period ]
- Percentage of alloimmunisation events evaluated with irregular red cell antibodies measure [ Time Frame: For each apherisis over a 12 months period ]
- Quality of life questionnaire (SF-36) [ Time Frame: At baseline and in 12 months ]
- Physician satisfaction survey for each participant [ Time Frame: Month 12 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076683
| Contact: Pablo BARTOLUCCI | +33 1 49 81 24 40 | pablo.bartolucci@aphp.fr | |
| Contact: Elena FOIS | +33 1 49 81 24 40 | elena.fois@aphp.fr |
| France | |
| EFS Rhône-Alpes-Auvergne | |
| Saint-Priest-en-Jarez, Auvergne Rhône-Alpes, France, 42277 | |
| Contact: Christine AUBREGE-BOUVIER +33 4 77 92 85 66 | |
| Centre de Santé EFS | |
| Besançon, Bourgogne Franche-Comté, France, 25000 | |
| Contact: Antoine CARPI +33 3 81 61 56 15 | |
| Centre de Santé EFS | |
| Rennes, Bretagne, France, 35016 | |
| Contact: Cathy DUGOR +33 2 23 22 53 95 | |
| Centre de Santé EFS | |
| Tours, Centre-Val De Loire, France, 37206 | |
| Contact: Béatrice HERAULT +33 2 47 36 01 14 | |
| CHU Kremlin Bicêtre | |
| Le Kremlin-Bicêtre, Ile De France, France, 94270 | |
| Contact: Christelle CHANTALAT +33 1 45 21 71 10 | |
| Hôpital Henri Mondor | |
| Créteil, Ile-de-France, France, 94010 | |
| Contact: Dehbia MENOUCHE +33 1 49 81 42 49 | |
| Centre de Santé EFS | |
| Bordeaux, Nouvelle-Aquitaine, France, 33035 | |
| Contact: Florian THEVENOT +33 5 56 90 82 03 | |
| Martinique | |
| CHU de Martinique | |
| Le Lamentin, Martinique, 97232 | |
| Contact: Gylna LOKO +33 5 96 48 81 89 | |
| Principal Investigator: | Pablo BARTOLUCCI | Henri Mondor University Hospital |
| Responsible Party: | Etablissement Français du Sang |
| ClinicalTrials.gov Identifier: | NCT04076683 |
| Other Study ID Numbers: |
2016-A01411-50 |
| First Posted: | September 3, 2019 Key Record Dates |
| Last Update Posted: | September 3, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Algorithm Apherisis Sickle cell patients |
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Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |