Validation d’Une Stratégie de Programme Transfusionnel Par Erythraphérèse basée Sur un Algorithme d’Aide à la Prescription Transfusionnelle Chez Les Patients Adultes Drépanocytaires

Study point of contact

Elena FOIS
+33 1 49 81 24 40
[email protected]
Pablo BARTOLUCCI
+33 1 49 81 24 40
[email protected]

Locations

7 France sites

1 Martinique site

Age

> 18 Years

Genotypes

HbSS

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Device

Compensation

Unknown

About the study

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.

participation requirements

– 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

participation restrictions

– 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

Locations

  • Saint-Priest-en-Jarez, Auvergne Rhône-Alpes, France, EFS Rhône-Alpes-Auvergne, 42277
  • Besançon, Bourgogne Franche-Comté, France, Centre de Santé EFS, 25000
  • Rennes, Bretagne, France, Centre de Santé EFS, 35016
  • Tours, Centre-Val De Loire, France, Centre de Santé EFS, 37206
  • Le Kremlin-Bicêtre, Ile De France, France, CHU Kremlin Bicêtre, 94270
  • Créteil, Ile-de-France, France, Hôpital Henri Mondor, 94010
  • Bordeaux, Nouvelle-Aquitaine, France, Centre de Santé EFS, 33035
  • Le Lamentin, Martinique, CHU de Martinique, 97232