October, 10 2019

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

Locations

7 France sites, 1 Martinique site

Age

> 18 Years

Genotypes

SS

Phase

N/A

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.

Study Type

Interventional

Phase

N/A

Age

> 18 Years

Genotype

SS

Gender

All

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

Interventions

  • Device

Outcome measures

  • Number of patients with individually achieved objectives in terms of % HbS

Location

  • EFS Rhône-Alpes-Auvergne, Saint-Priest-en-Jarez, Auvergne Rhône-Alpes, France, 42277 [Not yet recruiting]
  • Centre de Santé EFS, Besançon, Bourgogne Franche-Comté, France, 25000 [Not yet recruiting]
  • Centre de Santé EFS, Rennes, Bretagne, France, 35016 [Not yet recruiting]
  • Centre de Santé EFS, Tours, Centre-Val De Loire, France, 37206 [Not yet recruiting]
  • CHU Kremlin Bicêtre, Le Kremlin-Bicêtre, Ile De France, France, 94270 [Not yet recruiting]
  • Hôpital Henri Mondor, Créteil, Ile-de-France, France, 94010 [Not yet recruiting]
  • Centre de Santé EFS, Bordeaux, Nouvelle-Aquitaine, France, 33035 [Not yet recruiting]
  • CHU de Martinique, Le Lamentin, Martinique, 97232 [Not yet recruiting]

Contact Research Team

  • Elena FOIS
    +33 1 49 81 24 40
  • Pablo BARTOLUCCI
    +33 1 49 81 24 40

More info

View on ClinicalTrials
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