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临床试验/NCT00302900
NCT00302900已完成2 期

Preventing Adverse Reactions in Novice Blood Donors

Ohio University4 个研究点 分布在 1 个国家目标入组 441 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
441
试验地点
4
主要终点
Participant ratings of negative (vasovagal) reactions

研究概览

简要总结

Many individuals experience negative reactions when donating blood, including dizziness, lightheadedness, or fainting. Such reactions may discourage them from donating again. This study will evaluate the effectiveness of pre-donation water consumption and a muscle tensing exercise during donation to reduce negative reactions among new blood donors. This study will also evaluate whether reducing negative reactions increases the likelihood of donors returning to give blood in the future.

详细描述

Severe and potentially dangerous shortages in the blood supply are increasingly common in the United States. As the population ages and as more stringent donor eligibility restrictions are enforced, blood shortages are expected to worsen. One way to meet the increasing demand for blood is to recruit new blood donors. Ideally, these individuals would become lifelong donors, and contribute up to six times per year and up to hundreds of units of blood within a lifetime. Unfortunately, less than half of all new donors provide a second donation. Many individuals who donate blood experience dizziness, weakness, lightheadedness, or in severe cases, fainting. As a result of these negative reactions, many individuals never donate blood again. Preventing these reactions may be an effective way to encourage subsequent blood donations. The purpose of this study is to evaluate the effectiveness of consuming water prior to donation and performing a muscle tensing exercise during donation as ways to reduce negative reactions in new blood donors. The study's long-term goal is to provide blood collection agencies with simple and inexpensive strategies to prevent negative reactions and enhance donor retention.

This study will enroll American Red Cross blood donors who have donated blood no more than twice previously. Participants will be randomly assigned to one of the following four groups: 1) pre-donation water consumption and muscle tensing exercise during donation; 2) pre-donation water consumption; 3) pre-donation muscle tensing exercise; or 4) no treatment. Participant reactions will be assessed at the time of donation by self-report and phlebotomist ratings, as well as by self-report 24 hours following the donation. Participants' subsequent donation history will be tracked for two years by reviewing the American Red Cross national donor database.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Must meet American Red Cross donor eligibility requirements

排除标准

  • No more than two prior blood donations

结局指标

主要结局

Participant ratings of negative (vasovagal) reactions

时间窗: Measured within 30 minutes of donating

Number of repeat donations

时间窗: Measured 2 years post-donation

Phlebotomist ratings of donor reactions

时间窗: Measured immediately following donation

次要结局

  • Subjective ratings of muscle soreness and fatigue(Measured 24 hours post-donation)
  • Negative (vasovagal) reactions(Measured 24 hours post-donation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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