Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D
Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D
研究概览
详细说明
Background:
Idiopathic thrombocytopenic purpura (ITP) in children is considered a benign hematological disease. The incidence is approximately 50 cases a year in Denmark. Approximately 25 % will experience chronic disease. Follow up and treatment of these patients is not centralized.
The drug of choice is intravenous IgG (IVIG) for treatment of ITP. The side effects are flu-like symptoms, and in rare cases aseptic meningitis. Another option is intravenous anti-D, if the child is rhesus positive. Anti-D is primarily used in North America. The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50,000/μL. Anti-D also causes flu-like symptoms. Establishing an i.v. access is a disadvantage to both IVIG and anti-D. For both treatments mechanism of action is not finally described.
Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia. It is therefore known, that immunoglobulin uptake is possible after subcutaneous administration. Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results.
IVIG treatment is expensive compared to anti-D. Treatment of a 20 kg child costs approximately 17,000 Dkr for IVIG and 2,500 Dkr. for anti-D.
Hypothesis:
- Subcutaneous administered anti-D is as effective as IVIG/i.v. anti-D;
- Subcutaneous administered anti-D has fewer less severe side effects than IVIG/i.v. anti-D.
Purpose:
- To document the effect of subcutaneous anti-D;
- Describe complications;
- Describe aspects of the mechanism of action.
Material and Methods:
Children are eligible if admitted to a pediatric department in Denmark for diagnosis, observation or treatment of acute or chronic ITP. Examination and diagnostic work up is similar throughout the country, but not identical. No specific tests are required for diagnosis. If treatment is indicated rhesus positive children are treated with subcutaneous anti-D. Rhesus negative children are treated according to local guidelines. Specified follow-up on all children is mandatory. For research purposes one blood sample form all children is collected, and from children, who receive medical treatment, several blood samples are collected. Analysis for changes in immunological signaling peptides will be performed with special attention to the mechanism of action of anti-D.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Aalborg、丹麦、9100
- Aalborg University Hospital, Department of Pediatrics
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Aarhus N、丹麦、8200
- Skejby Hospital, Aarhus University Hospital, Department of Pediatrics
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Copenhagen S、丹麦、2300
- Amager Hospital, Department of Pediatrics
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Copenhagen Ø、丹麦、2100
- Rigshospitalet, Copenhagen University Hospital, Pediatric Clinic II
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Esbjerg、丹麦、6700
- Esbjerg Hospital, Department of Pediatrics
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Gentofte、丹麦、2900
- Gentofte Hospital, Department of Pediatrics
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Herning、丹麦、7400
- Herning Hospital, Department of Pediatrics
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Hjoerring、丹麦、9800
- Hjoerring Hospital, Department of Pediatrics
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Holbæk、丹麦、4300
- Holbæk Hospital, Department of Pediatrics
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Hvidovre、丹麦、2650
- Hvidovre Hospital, Department of Pediatrics
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Kolding、丹麦、6000
- Kolding Hospital Department of Pediatrics
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Nykøbing F、丹麦、4800
- Nykøbing F, Department of Pediatrics
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Næstved、丹麦、4700
- Næstved Hospital, Department of Pediatrics
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Odense C、丹麦、5000
- Odense University Hospital
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Randers、丹麦、8900
- Randers Hospital, Department of Pediatrics
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Sønderborg、丹麦、6400
- Sønderborg Hospital, Department of Pediatrics
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Viborg、丹麦、8800
- Viborg Hospital, Department of Pediatrics
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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
描述
Inclusion Criteria:
- Idiopathic thrombocytopenic purpura (ITP)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Clinical effect evaluated on clinical score scale before and after treatment at specified intervals
大体时间:day 0,1,3,6,14,30, 180,360
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day 0,1,3,6,14,30, 180,360
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次要结果测量
结果测量 |
大体时间 |
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Platelet count
大体时间:day 0, 1, 3, 6, 14, 30, 180, 360
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day 0, 1, 3, 6, 14, 30, 180, 360
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合作者和调查者
调查人员
- 研究主任:Mimi Kjaersgaard, MD、University of Aarhus, Clinical Institute, Department of Pediatrics
- 首席研究员:Henrik Hasle, MD PhD、Skejby Hospital, University of Aarhus, Department of Pediatrics
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 (估计)
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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