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临床试验/NCT01534117
NCT01534117已完成不适用

Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL

Chang, Steve S., M.D.1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
97
试验地点
1
主要终点
Platelet inhibition

研究概览

简要总结

The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.

详细描述

The platelet function analyzer VerifyNow® P2Y12 uses ADP as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. VerifyNow® Aspirin Assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. Our research question for this study is as follows:

Does the administration of desmopressin (DDAVP) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by Aspirin and/or Plavix? The investigators hypothesize that with the administration of platelets and/or DDAVP that there is a reversal of the inhibition.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • Age > 18yrs
  • Must be a trauma patient with blunt head trauma.
  • Must be on Aspirin and/or Plavix
  • Subject or Legally Authorized Representative (LAR) (per Heath and Safety Code, Sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (If this criterion is not met the initial blood draw must be destroyed and NOT run for study results).

排除标准

  • Hemoglobin ≤ 10 GM/DL
  • Platelet Count ≤ 150 K/MCL
  • Pregnant Females
  • Subjects on Warfarin, Heparin or Enoxaparin

研究组 & 干预措施

Platelets/DDAVP

Active Comparator

Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP

干预措施: Platelets (Biological)

Platelets/DDAVP

Active Comparator

Fall on ASA/Plavix that sustained head trauma requiring administration of platelets and/or DDAVP

干预措施: DDAVP (Drug)

结局指标

主要结局

Platelet inhibition

时间窗: 8 hours

We are measuring platelet inhibition using the verify now platelet function analyzer

次要结局

未报告次要终点

研究者

发起方
Chang, Steve S., M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (1)

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