Hydroxyurea in the Treatment of Sickle Cell Disease
Hydroxyurea in Sickle Cell Disease: a Large Nation-wide Cohort Study From Italy
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bari、意大利
- Azienda Ospedaliero-Universitaria
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Brescia、意大利、25100
- U.O. Oncoematologia Pediatrica Ospedali Civili
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Brindisi、意大利、72100
- Ospedale "A. Perrino"
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Cagliari、意大利、09121
- Azienda Ospedaliera Universitaria di Cagliari
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Catania、意大利、95123
- Ospedale Vittorio Emanuele
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Catania、意大利、95124
- ARNAS "Garibaldi"
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Catania、意大利、95124
- University of Catania
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Catanzaro、意大利、88100
- A.O. "Pugliese-Ciaccio"
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Crotone、意大利
- Osp.San Giovanni Di Dio
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Firenze、意大利、50139
- Azienda Ospedaliero Universitaria Meyer
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Genova、意大利、16128
- E.O. Ospedali Galliera
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Milano、意大利、20122
- Universita degli Studi di Milano
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Modena、意大利、41124
- Azienda Ospedaliero-Universitaria di Modena - Policlinico
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Monza、意大利、20900
- Azienda Ospedaliera San Gerardo di Monza
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Monza、意大利、20052
- Clinica pediatrica Monza S. Gerardo
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Napoli、意大利
- AORN A. Cardarelli
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Padova、意大利、35128
- Clinica di Onco-Ematologia Pediatrica, Università di Padova
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Palermo、意大利、90146
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
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Palermo、意大利、90100
- A.R.N.A.S. "Civico"
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Parma、意大利、43126
- Azienda Ospedaliero-Universitaria di Parma
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Pavia、意大利、27100
- Policlinico San Matteo
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Ravenna、意大利、48121
- Centro Emofilia e Medicina Trasfusionale - Pres. Ospedaliero
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Reggio Calabria、意大利、89100
- A. O. Bianchi Melacrino Morelli
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Roma、意大利、00144
- Ospedale S. Eugenio - FF UOSD DH Talassemici
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Roma、意大利、00168
- Università Cattolica del Sacro Cuore - Policlinico A.Gemelli
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Siracusa、意大利、96100
- U.O.S. Talassemia P.O. Umberto I°
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Torino、意大利、90146
- Università degli Suidi di Torino
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Verona、意大利、37122
- Policlinico G.B. Rossi
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Agrigento
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Sciacca、Agrigento、意大利、92019
- Ospedali Civili Riuniti di Sciacca
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Caltanisetta
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Gela、Caltanisetta、意大利、93012
- Ospedale Vittorio Emanuele III
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Sickle Cell Disease affected patients
- 2-3 vaso-occlusive crisis and/or hospitalizations in the last year
Exclusion Criteria
- none
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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SCD patients
Patients followed in 32 Italian Centers.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in laboratory parameters is being assessed
大体时间：An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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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.
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An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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Changes in complication rates is being assessed
大体时间：An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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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.
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An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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Rate of hospitalizations
大体时间：An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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Changing in rate of hospitalizations before and after start hydroxyurea therapy
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An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changing in the incidence of complications according to specific subgroups
大体时间：An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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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).
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An average of 3 years before and an average of 3 years after initiation of hydroxyurea therapy
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合作者和调查者
调查人员
- 首席研究员：Paolo Rigano, MD、Servico Integrado de Tecnicas Endovasculares
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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