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临床试验/NCT00131040
NCT00131040已完成不适用

Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass

Imperial College London2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2003年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups

研究概览

简要总结

The purpose of this study was to see if the heart-lung machine involved in cardiac surgery increases the movement of activated white blood cells from the bloodstream into the patient's tissues and also to see if aprotinin usage during surgery reduces this effect.

详细描述

It has long been known that exposure of blood to the heart-lung bypass machine can trigger a whole-body inflammatory response in cardiac surgery patients that is linked to activation of circulating white blood cells. The investigators propose to use a technique to track the movement of white blood cells into the skin of patients during bypass surgery. The skin blisters will be elicited by application of the blistering agent cantharidin to the forearm of volunteer patients. This will allow the investigators to study the activation state of white blood cells that enter tissues during bypass surgery and to determine whether aprotinin has any beneficial effect with regards to inflammatory status of these cells.

The investigators propose that white blood cell trafficking into the blisters will increase following the use of the heart-lung machine and that the effect of aprotinin will be to ablate this.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary elective coronary artery bypass surgery

排除标准

  • Emergent, urgent or re-do surgery
  • Patients on oral corticosteroid medication
  • Patients on aspirin therapy < 7 days prior to operation

结局指标

主要结局

Comparison of the number of extravasated leukocytes in the skin blisters pre- and post-operatively, in both the placebo and aprotinin treatment groups

次要结局

  • The activation status of the blister leukocytes and the level of soluble inflammatory mediators within the blister

研究者

申办方类型
Other

研究点 (2)

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