Hydroxyurea in the Treatment of Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT02709681|
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment|
|Sickle Cell Disease||Other: Physician standard-of-care in SCD patients|
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.
|Study Type :||Observational|
|Actual Enrollment :||628 participants|
|Official Title:||Hydroxyurea in Sickle Cell Disease: a Large Nation-wide Cohort Study From Italy|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||July 2017|
Patients followed in 32 Italian Centers.
Other: Physician standard-of-care in SCD patients
- 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 ]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.
- 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 ]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.
- Rate of hospitalizations [ Time Frame: An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy ]Changing in rate of hospitalizations before and after start hydroxyurea therapy
- 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 ]We also stratified the analysis according to age (≥18 years), origin (Italian and African), genotype (βS/β0, βS/β+ and βS/βS) duration of hydroxyurea treatment (≥10 years) and hydroxyurea dose(≥15 mg/kg/day).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709681
|Principal Investigator:||Paolo Rigano, MD||Servico Integrado de Tecnicas Endovasculares|