Hydroxyurea in the Treatment of Sickle Cell Disease
Hydroxyurea in Sickle Cell Disease: a Large Nation-wide Cohort Study From Italy
1 other identifier
observational
628
1 country
30
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedOctober 6, 2017
March 1, 2016
1 year
March 1, 2016
October 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Changes in laboratory parameters is being assessed
Increases or decreases in percentage of total hemoglobin, fetal hemoglobin and hemoglobin S level will be assessed. Changing of white blood cells and platelets counts, lactate dehydrogenase, bilirubin, aspartate aminotransferase and serum creatinine level will be also evaluated.
An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
Changes in complication rates is being assessed
Changing in the incidence of stroke, silent cerebral infraction, acute chest syndrome, vaso-occlusive crisis, pulmonary hypertension, leg ulcers, bone necrosis and kidney injury will be evaluated.
An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
Rate of hospitalizations
Changing in rate of hospitalizations before and after start hydroxyurea therapy
An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
Secondary Outcomes (1)
Changing in the incidence of complications according to specific subgroups
An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
Study Arms (1)
SCD patients
Patients followed in 32 Italian Centers.
Interventions
Eligibility Criteria
A population of SCD (Homozigous HbS and Beta Thal /HbS) patients followed in 32 Italian Centers was included in this analysis.
You may qualify if:
- Sickle Cell Disease affected patients
- vaso-occlusive crisis and/or hospitalizations in the last year
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Ospedali Civili Riuniti di Sciacca
Sciacca, Agrigento, 92019, Italy
Ospedale Vittorio Emanuele III
Gela, Caltanisetta, 93012, Italy
Azienda Ospedaliero-Universitaria
Bari, Italy
U.O. Oncoematologia Pediatrica Ospedali Civili
Brescia, 25100, Italy
Ospedale "A. Perrino"
Brindisi, 72100, Italy
Azienda Ospedaliera Universitaria Di Cagliari
Cagliari, 09121, Italy
Ospedale Vittorio Emanuele
Catania, 95123, Italy
ARNAS "Garibaldi"
Catania, 95124, Italy
University of Catania
Catania, 95124, Italy
A.O. "Pugliese-Ciaccio"
Catanzaro, 88100, Italy
Osp.San Giovanni Di Dio
Crotone, Italy
Azienda Ospedaliero Universitaria Meyer
Florence, 50139, Italy
E.O. Ospedali Galliera
Genova, 16128, Italy
Università degli Studi di Milano
Milan, 20122, Italy
Azienda Ospedaliero-Universitaria di Modena - Policlinico
Modena, 41124, Italy
Clinica pediatrica Monza S. Gerardo
Monza, 20052, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, 20900, Italy
Aorn A. Cardarelli
Napoli, Italy
Clinica di Onco-Ematologia Pediatrica, Università di Padova
Padua, 35128, Italy
A.R.N.A.S. "Civico"
Palermo, 90100, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126, Italy
Policlinico San Matteo
Pavia, 27100, Italy
Centro Emofilia e Medicina Trasfusionale - Pres. Ospedaliero
Ravenna, 48121, Italy
A. O. Bianchi Melacrino Morelli
Reggio Calabria, 89100, Italy
Ospedale S. Eugenio - FF UOSD DH Talassemici
Roma, 00144, Italy
Università Cattolica del Sacro Cuore - Policlinico A.Gemelli
Roma, 00168, Italy
U.O.S. Talassemia P.O. Umberto I°
Syracuse, 96100, Italy
Università degli Suidi di Torino
Torino, 90146, Italy
Policlinico G.B. Rossi
Verona, 37122, Italy
Related Publications (1)
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.
PMID: 29107441DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Rigano, MD
Servico Integrado de Tecnicas Endovasculares
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2016
First Posted
March 16, 2016
Study Start
November 1, 2015
Primary Completion
November 1, 2016
Study Completion
July 1, 2017
Last Updated
October 6, 2017
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share