Overview

This trial is active, not recruiting.

Condition sickle cell disease
Treatment physician standard-of-care in scd patients
Sponsor Società Italiana Talassemie ed Emoglobinopatie
Start date November 2015
End date March 2016
Trial size 628 participants
Trial identifier NCT02709681, SocietaITE

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients followed in 32 Italian Centers.
physician standard-of-care in scd patients

Primary Outcomes

Measure
Changes in laboratory parameters is being assessed
time frame: An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
Changes in complication rates is being assessed
time frame: An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
Rate of hospitalizations
time frame: An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy

Secondary Outcomes

Measure
Changing in the incidence of complications according to specific subgroups
time frame: An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy

Eligibility Criteria

Male or female participants at least 1 year old.

Inclusion Criteria: - Sickle Cell Disease affected patients - 2-3 vaso-occlusive crisis and/or hospitalizations in the last year Exclusion Criteria

Additional Information

Official title Hydroxyurea in Sickle Cell Disease: a Large Nation-wide Cohort Study From Italy
Principal investigator Paolo Rigano, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Società Italiana Talassemie ed Emoglobinopatie.