Clinical Trial
Study Details
This is a retrospective cohort study of Sickle Cell Disease (SCD) patients attending 32 treatment centers across Italy. The aim of this study will be to report the Italian experience with the use of hydroxyurea in a large cohort of SCD patients and to evaluate the benefits and safety of this intervention for the prevention and management of a wide range of clinical morbidities
Study Overview
The indication for hydroxyurea initiation was 2-3 vaso-occlusive crisis and/or hospitalizations in the last year.
The study will analyze demographics (age and gender), origin, genotype, clinical phenotype (vaso-occlusive or hemolytic), transfusion history (including exchange), and folic acid use, average laboratory values up to three years pre-hydroxyurea and for the period post-hydroxyurea therapy including total hemoglobin level, fetal hemoglobin level, hemoglobin S level, white blood count, platelet count, lactate dehydrogenase level, total and direct bilirubin levels, aspartate and alanine aminotransferase levels, and serum creatinine level.
The incidence of complications pre- and post-hydroxyurea therapy will be also analyzed including: stroke, silent cerebral infraction, acute chest syndrome, vaso-occlusive crisis, hospitalization, pulmonary hypertension, leg ulcers, bone necrosis, and kidney injury. Safety data included adverse events as reported by the treating physician and the incidence of malignancy or death as well as pregnancy incidents and their outcomes will be also pointed out.
Contacts and Locations
Ospedali Civili Riuniti di Sciacca
92019 Sciacca Agrigento
Italy
Ospedale Vittorio Emanuele III
93012 Gela Caltanisetta
Italy
Azienda Ospedaliero-Universitaria
Bari
Italy
U.O. Oncoematologia Pediatrica Ospedali Civili
25100 Brescia
Italy
Ospedale "A. Perrino"
72100 Brindisi
Italy
Azienda Ospedaliera Universitaria Di Cagliari
09121 Cagliari
Italy
Ospedale Vittorio Emanuele
95123 Catania
Italy
ARNAS "Garibaldi"
95124 Catania
Italy
University of Catania
95124 Catania
Italy
A.O. "Pugliese-Ciaccio"
88100 Catanzaro
Italy
Osp.San Giovanni Di Dio
Crotone
Italy
Azienda Ospedaliero Universitaria Meyer
50139 Florence
Italy
E.O. Ospedali Galliera
16128 Genova
Italy
Università degli Studi di Milano
20122 Milan
Italy
Azienda Ospedaliero-Universitaria di Modena - Policlinico
41124 Modena
Italy
Clinica pediatrica Monza S. Gerardo
20052 Monza
Italy
Azienda Ospedaliera San Gerardo di Monza
20900 Monza
Italy
Aorn A. Cardarelli
Naples
Italy
Clinica di Onco-Ematologia Pediatrica, Università di Padova
35128 Padova
Italy
A.R.N.A.S. "Civico"
90100 Palermo
Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
90146 Palermo
Italy
Azienda Ospedaliero-Universitaria di Parma
43126 Parma
Italy
Policlinico San Matteo
27100 Pavia
Italy
Centro Emofilia e Medicina Trasfusionale - Pres. Ospedaliero
48121 Ravenna
Italy
A. O. Bianchi Melacrino Morelli
89100 Reggio Calabria
Italy
Ospedale S. Eugenio - FF UOSD DH Talassemici
00144 Roma
Italy
Università Cattolica del Sacro Cuore - Policlinico A.Gemelli
00168 Roma
Italy
U.O.S. Talassemia P.O. Umberto I°
96100 Syracuse
Italy
Università degli Suidi di Torino
90146 Torino
Italy
Policlinico G.B. Rossi
37122 Verona
Italy