National Transfusion Treatment Survey in Patients With Sickle Cell Disease (SCD)

Study type

Observational

Gender

All

Interventions

Other

Compensation

Unknown

About the study

The “National Transfusion Treatment Survey in patients with sickle cell disease (SCD)” is a
prospective longitudinal systemic study that was created in order to evaluate the therapeutic
approach, mainly transfusional, in patients affected by SCD throughout Italy and to improve
the quality of care and implement research.

The survey will evaluate all patients affected by different forms of sickle cell disease (HbS
homozygosis, Thalassoso-drepanocytosis, HbS / HbC compound heterozygosis, other possible
genetic compounds).

Patients will be selected according with a SCD diagnosis confirmed by standardized
biochemical criteria or by DNA analysis. Patients will be excluded from the study who do not
meet the these requirements, who are unable to understand the protocol or able to give
informed consent in the absence of any legal representative.

All data will be collected through a standard web-based application, which will be completed
by the responsable investigator or by sub-investigators selected by each center, after
registration on the site providing personal data and indicating the affiliation structure.
All data will be subsequently encrypted by the Central Server. The operator will subsequently
be able to access the patient’s clinical data to perform the updates, in order to follow the
patient’s clinical evolution over time. The study will not involve any additional tests
compared to the routine of patient control.

participation requirements

– patients suffering of sickle cell disease, with diagnosis confirmed by standardized
biochemical criteria or by matching mutations on globin genes by DNA analysis;

– all patients who consent to the study by signing the informed consent given by the
U.O.C.

participation restrictions

– patients without a diagnosis confirmed according to standardized biochemical criteria
or via mutation on globin genes by DNA analysis.

– all patients unable to understand the study protocol and to give informed consent and
who have no legal representative.