Microparticles in Scuba Divers With Decompression Sickness
2016年8月18日 更新者:University of Pennsylvania
Phase 1 Study Investigating Alterations of Circulating Microparticles in Scuba Divers With Decompression Sickness
The investigators hypothesize that membrane microparticles (MPs) are liberated into the blood stream in response to decompression stress and that certain MPs characteristics initiate inflammatory responses that contribute to the clinical syndrome the investigators call decompression sickness.
The research goal is to evaluate the number, type and time-course for elevations in MPs in sport SCUBA divers who present for treatment of decompression sickness.
Blood samples are to be taken from consenting patients before and after they undergo treatment for decompression sickness and at a follow-up clinic visit from 1 to 3 weeks later (three samples total).
研究概览
详细说明
Microparticles (MPs) are small membrane bound vesicles shed from the surface of a variety of cells by what appear to be well regulated processes.
They are elevated in many physiological and disease states and in some instances have been associated with organ injury.
Shear stress - as can be caused by intravascular bubbles - is one of the stimuli known to cause cells to release microparticles.
Most sport SCUBA dives have been shown to generate intravascular bubbles - even safe dives well within limits established by the US Navy and sports authorities.
The investigators have reported elevations in several sub-types of MPs in a group of individuals undergoing a well monitored series of open-water SCUBA dives.
There is no information of the occurrence of MPs in injured divers.
The investigators have published results using a murine model which demonstrated that mice subjected to varying decompression stresses exhibit progressive elevations in circulating MPs derived from leukocytes, erythrocytes, platelets and endothelial cells.
Using novel interventions the investigators demonstrated that MPs cause intravascular neutrophil activation and inflammatory perivascular injuries.
Therefore, there is pathophysiological information to suggest that one or more element of MPs (number and/or pro-inflammatory subtype) may be proximal elements that precipitate the clinical syndrome the investigators call decompression sickness.
研究类型
观察性的
注册 (实际的)
1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104-6068
- University of Pennsylvania
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
SCUBA divers over age 21 that present for evaluation of suspected decompression sickness
描述
Inclusion Criteria:
- Patients who are given the diagnosis of decompression sickness will be offered entry into this study
Exclusion Criteria:
- Inability to provide informed consent
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
队列和干预
团体/队列 |
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Divers with decompression sickness
The sole group under study is SCUBA divers who have sustained decompression sickness
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Microparticle elevations in injured divers
大体时间:four years
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We will quantify microparticles in plasma by standard flow cytometry techniques.
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four years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Microparticle sub-types in injured divers
大体时间:four years
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We will evaluate sub-types of microparticles to determine their cells of origin.
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four years
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Neutrophil activation in injured divers
大体时间:four years
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We will evaluate presence of neutrophil activation in injured divers.
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four years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Stephen R Thom, MD,PhD、University of Pennsylvania
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Thom SR, Yang M, Bhopale VM, Huang S, Milovanova TN. Microparticles initiate decompression-induced neutrophil activation and subsequent vascular injuries. J Appl Physiol (1985). 2011 Feb;110(2):340-51. doi: 10.1152/japplphysiol.00811.2010. Epub 2010 Oct 21.
- Yang M, Milovanova TN, Bogush M, Uzun G, Bhopale VM, Thom SR. Microparticle enlargement and altered surface proteins after air decompression are associated with inflammatory vascular injuries. J Appl Physiol (1985). 2012 Jan;112(1):204-11. doi: 10.1152/japplphysiol.00953.2011. Epub 2011 Sep 29.
- Thom SR, Milovanova TN, Bogush M, Bhopale VM, Yang M, Bushmann K, Pollock NW, Ljubkovic M, Denoble P, Dujic Z. Microparticle production, neutrophil activation, and intravascular bubbles following open-water SCUBA diving. J Appl Physiol (1985). 2012 Apr;112(8):1268-78. doi: 10.1152/japplphysiol.01305.2011. Epub 2012 Feb 9.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年8月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2012年4月23日
首先提交符合 QC 标准的
2012年4月27日
首次发布 (估计)
2012年4月30日
研究记录更新
最后更新发布 (估计)
2016年8月22日
上次提交的符合 QC 标准的更新
2016年8月18日
最后验证
2016年8月1日
更多信息
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