ISRCTN52713285已完成不适用
Silent Cerebral Infarct Multi-Center Clinical Trial
ational Institute of Neurological Disorders and Stroke (NINDS) (USA)0 个研究点目标入组 250 人开始时间: 2004年10月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria amended as of 12/03/2008:
- •Inclusion Criteria for Screening:
- •1. Patient must have sickle cell anemia (hemoglobin SS or sickle B) as confirmed by the local institution by hemoglobin analysis after six months of age
- •2. Patient must be 5 through 14 years of age (i.e., must have attained their 5th, but not their 15th birthday when the screening consent is signed)
- •3. Informed consent with assent in accordance with the institutional policies
- •Inclusion criteria provided at time of registration:
- •1. Patients ages 6-12 with sickle cell anemia (Hemoglobin SS or SB)
- •2. Patient must have a silent cerebral infarct documented by magnetic resonance imaging (MRI) of the brain as read by the neuroradiology panel
排除标准
- •Exclusion criteria amended as of 12/03/2008:
- •Exclusion Criteria for Screening at initial screening evaluation and after informed consent has been signed as well as during the interval up to randomization:
- •1. Patient with a history of a focal neurologic event lasting more than 24 hours with medical documentation or a history of prior overt stroke
- •2. Patient with other neurological problems, such as neurofibromatosis, lead poisoning, non-febrile seizure disorder, or tuberous sclerosis
- •3. Patient with HIV infection
- •4. Pregnancy or lactating females
- •5. Patient who received treatment with anti-sickling drugs or hydroxyurea within 3 months or anticipate receiving anti-sickling drugs or hydroxyurea during the course of the study
- •6. Patients on chronic blood transfusion therapy for other reasons
- •7. Patient judged not likely to be compliant by his/her hematologist and study coordinator based on previous compliance in clinic appointments and following advice. Specifically, families that have missed at least two appointments without notification within 12 months prior to the trial or parents/guardians of potential patients that have been reported for medical or education neglect are not eligible for this trial
- •8. Patient unable to receive blood transfusion because of alloimmunization
- •9. Patients who have or anticipate receiving permanent (or semi-permanent) metallic structures attached to their body. (e.g., braces on teeth, body piercings), which their physicians believe will interfere with the MRI of the head to assess the presence of silent cerebral infarct
- •10. Patients with any person living in the same household who have been randomly assigned in the SIT Trial
- •Exclusion criteria provided at time of registration:
- •1. Patients with a history of overt stroke or focal neurological event lasting more than 24 hours
- •2. Patients with other neurological problems, such as neurofibromatosis, lead poisoning, or tuberous sclerosis
- •3. Patients with a transcranial doppler (TCD) study with a time-averaged mean velocity greater than 200 cm/sec verified by the study radiologist
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