Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
628 participants
OBSERVATIONAL
2015-11-30
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SCD patients
Patients followed in 32 Italian Centers.
Physician standard-of-care in SCD patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Physician standard-of-care in SCD patients
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2-3 vaso-occlusive crisis and/or hospitalizations in the last year
Exclusion Criteria
1 Year
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Società Italiana Talassemie ed Emoglobinopatie
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paolo Rigano, MD
Role: PRINCIPAL_INVESTIGATOR
Servico Integrado de Tecnicas Endovasculares
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedali Civili Riuniti di Sciacca
Sciacca, Agrigento, Italy
Ospedale Vittorio Emanuele III
Gela, Caltanisetta, Italy
Azienda Ospedaliero-Universitaria
Bari, , Italy
U.O. Oncoematologia Pediatrica Ospedali Civili
Brescia, , Italy
Ospedale "A. Perrino"
Brindisi, , Italy
Azienda Ospedaliera Universitaria Di Cagliari
Cagliari, , Italy
Ospedale Vittorio Emanuele
Catania, , Italy
ARNAS "Garibaldi"
Catania, , Italy
University of Catania
Catania, , Italy
A.O. "Pugliese-Ciaccio"
Catanzaro, , Italy
Osp.San Giovanni Di Dio
Crotone, , Italy
Azienda Ospedaliero Universitaria Meyer
Florence, , Italy
E.O. Ospedali Galliera
Genova, , Italy
Università degli Studi di Milano
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena - Policlinico
Modena, , Italy
Clinica pediatrica Monza S. Gerardo
Monza, , Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, , Italy
Aorn A. Cardarelli
Napoli, , Italy
Clinica di Onco-Ematologia Pediatrica, Università di Padova
Padua, , Italy
A.R.N.A.S. "Civico"
Palermo, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, , Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Policlinico San Matteo
Pavia, , Italy
Centro Emofilia e Medicina Trasfusionale - Pres. Ospedaliero
Ravenna, , Italy
A. O. Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Ospedale S. Eugenio - FF UOSD DH Talassemici
Roma, , Italy
Università Cattolica del Sacro Cuore - Policlinico A.Gemelli
Roma, , Italy
U.O.S. Talassemia P.O. Umberto I°
Syracuse, , Italy
Università degli Suidi di Torino
Torino, , Italy
Policlinico G.B. Rossi
Verona, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rigano P, De Franceschi L, Sainati L, Piga A, Piel FB, Cappellini MD, Fidone C, Masera N, Palazzi G, Gianesin B, Forni GL; Italian Multicenter Study of Hydroxyurea in Sickle Cell Anemia Investigators. Real-life experience with hydroxyurea in sickle cell disease: A multicenter study in a cohort of patients with heterogeneous descent. Blood Cells Mol Dis. 2018 Mar;69:82-89. doi: 10.1016/j.bcmd.2017.08.017. Epub 2017 Oct 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SocietaITE
Identifier Type: -
Identifier Source: org_study_id