NCT00808626撤回1 期
Phase II Investigation of 99mTc-rBitistatin for Imaging Venous Thrombosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi
研究概览
简要总结
99mTc-rBitistatin is a radiolabeled polypeptide which is designed to stick to blood clots so that the blood clots can be detected by imaging. The purpose of this trial is to evaluate in patients the safety of 99mTc-rBitistatin and its ability to locate blood clots in the arms and legs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •peripheral acute venous thrombosis diagnosed by vascular ultrasound
- •is able to give informed consent
- •is likely to complete the study
排除标准
- •is pregnant
- •is lactating
- •has a history of prior severe allergic reactions (anaphylactic response)
- •prior use of GP IIb/IIIa antagonist (e.g., abciximab, eptifibatide)
- •has a platelet count <100,000 or history of thrombocytopenia
- •has a history of stroke
- •has a history of recent bleeding documented by decreasing hemoglobin (>1 gm) in last 7 days
研究组 & 干预措施
99mTc-rBitistatin
Experimental
干预措施: 99mTc-rBitistatin (Drug)
结局指标
主要结局
Establish the proof of concept that 99mTc-rBitistatin enables imaging of peripheral venous thrombi
时间窗: 1-4 hours after administration
次要结局
- Continue to evaluate the safety of 99mTc-rBitistatin administered intravenously(0-4 hr, 6 hr, 3-4 weeks, 3-4 months after administration)
研究者
研究点 (1)
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