NCT00603824撤回4 期
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Platelet count recovery
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years of age;
- •If female of childbearing potential, negative pregnancy test result;
- •Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
- •Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).
排除标准
- •Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
- •Pregnancy or lactating;
- •Blood dyscrasia other than HIT;
- •History of thrombocytopenia associated with fondaparinux;
- •Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
- •Active bleeding of GI tract, GU tract, CNS or respiratory tract;
- •Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
- •Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
- •Hypersensitivity or contraindication to warfarin or fondaparinux.
研究组 & 干预措施
A
Experimental
Fondaparinux
干预措施: fondaparinux (Drug)
B
Active Comparator
Direct thrombin inhibitor
干预措施: argatroban or lepirudin (Drug)
结局指标
主要结局
Platelet count recovery
时间窗: 5 days
次要结局
- Recurrent thromboembolic complications(4 weeks)
研究者
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