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临床试验/NCT01758653
NCT01758653Enrolling By Invitation不适用

Carbon Monoxide Blood and DNA Repository

Intermountain Health Care, Inc.2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
2
主要终点
Biorepository for serum and plasma

研究概览

简要总结

The purpose of this biorepository is to collect blood from patients at the time of CO poisoning and at follow-up visits months to years later. These samples can be used in the future to learn more about how CO damages the heart and brain and whether blood tests could predict which patients will have problems after CO poisoning.

详细描述

The investigators propose to establish a biorepository for storage of serum, plasma, and DNA collected from patients with carbon monoxide (CO) poisoning. Participants will also be evaluated for clinical outcome. The biorepository will include serum and plasma from CO-poisoned patients drawn at the time of injury as well as from blood drawn at clinical follow-up visits. The biorepository will also bank DNA from these participants.

These specimens can be analyzed in the future to elucidate potential inflammatory and immunological mechanisms that cause brain and heart damage and identify possible biological and genetic predictors of poor outcome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Symptomatic carbon monoxide poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, loss of consciousness, etc.).
  • Documented exposure to carbon monoxide and no other reasonable explanation for their signs and symptoms.
  • Exclusion criteria:
  • Age < 18 years
  • Unable to obtain informed consent
  • Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. The investigator and the Sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria.
  • Anemia requiring blood products within the last 4 months or hematocrit less than the laboratory normal reference range

排除标准

  • 未提供

结局指标

主要结局

Biorepository for serum and plasma

时间窗: Within 24 hours of CO Poisoning

Serum and plasma from blood collected within 24 hours of acute CO poisoning

次要结局

  • Serum and plasma (sub-acute)(4 weeks to 4 months after CO poisoning)
  • DNA Sequestration(24 hours to 12 months after CO poisoning)
  • Serum and plasma (long-term)(4 months to 12 months after CO poisoning)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lindell Weaver

Lindell Weaver, MD

Intermountain Health Care, Inc.

研究点 (2)

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