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临床试验/NCT00489437
NCT00489437已完成1 期

Improving the Diagnosis of Heparin-Induced Thrombocytopenia: Utility of the 4T's Score and Evaluation of New Rapid Assays

McMaster University2 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
536
试验地点
2
主要终点
Proportion of patients with a low or intermediate 4T's Score and a negative ID-PaGIA assay result who have a positive SRA.

研究概览

简要总结

Main Research Question:

Can two new types of test, one called the 4T's score and the other called a rapid assay, help doctors correctly identify which patients are unlikely to have heparin-induced thrombocytopenia (HIT)?

HIT is a severe allergic reaction to the blood thinner heparin. This allergic reaction can lead to heart attacks, strokes, limb amputations, and death. Because heparin is one of the most commonly used drugs in the hospital setting, it is very important that the investigators are able to correctly identify who can safely continue to take heparin and who cannot.

It can be very difficult to diagnose HIT because it can look like many other medical conditions and the best laboratory tests for HIT are difficult to run and only available at specialized centres.

It would be very helpful if doctors had tests they could use that would tell them quickly and accurately which patients with symptoms that look like HIT really do have HIT (and require urgent treatment with another type of blood thinner) and which patients are very unlikely to have HIT (and could continue to take heparin safely). In this study, the investigators will compare the 4T's score (a scoring system that assigns "points" to the presence or absence of specific clinical features) and a rapid laboratory test with the old laboratory test to find out if one or both of these types of tests are useful for telling doctors which patients have HIT and which patients don't have HIT.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Suspected heparin-induced thrombocytopenia

排除标准

  • Unable to give consent
  • Unable to provide a blood sample
  • Previous entered in study

结局指标

主要结局

Proportion of patients with a low or intermediate 4T's Score and a negative ID-PaGIA assay result who have a positive SRA.

时间窗: 30 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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