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Effects of Blood Transfusion in Healthy Volunteers

2014年1月29日 更新者:Warren M. Zapol、Massachusetts General Hospital

Effects of Duration of Stored Red Blood Cell Transfusion on Physiological Parameters and Inflammatory Mediators in Healthy Adult Volunteers

The objective of this study is to assess effects of the storage of PRBC on endothelial function, inflammation and platelet activation in healthy volunteers

研究概览

地位

完全的

详细说明

The objective of this study is to assess effects of the storage of PRBC on endothelial function, inflammation and platelet activation in healthy volunteers.

The present study consists of two parts. During one phase of the study, 10 healthy human volunteers will donate a unit of blood, which will be leukoreduced and stored in Additive Solutions-1 (AS-1), and then transfused back to the subjects after 2 days of storage at 4º C in the MGH Blood Bank. The other part of the study consists in the collection of a unit of blood from the same volunteers, but which will be transfused back to the same subject after 40 days of storage. There will be a break of 2 week period in between these 2 study phases. The order of these 2 study parts will be randomized.

We hypothesize that old red blood cells stored under conventional conditions may trigger a complex, pro-inflammatory, pro-thrombotic and vasoconstriction response. We will compare the response to PRBC stored for 2 days with the response to PRBC stored for 40 days in the same healthy volunteers. We will monitor/measure the following markers/parameters:

  1. Endothelium-mediated changes in vascular (arterial) tone
  2. Tissue oxygen saturation will be continuously assessed during and after blood transfusion
  3. Hemolysis as quantified by changes in plasma haptoglobin level, plasma free hemoglobin, LDH level, bilirubin level, iron level, ferritin, and transferrin
  4. Changes of plasma and red blood cell levels of circulating nitrate, nitrite, RXNO, RNNO, NO-heme
  5. Concentration of cytokines, such as IL-6, IL-8, IL-10, IL-12, TNF, IFN-γ
  6. Activation of platelets through circulating P-selectin expression on platelets
  7. Activation of inflammatory lipid mediators
  8. Changes in gene expression profiling analyzing RNA microarray of circulating leukocytes

研究类型

介入性

注册 (实际的)

10

阶段

  • 不适用

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

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital (MGH)

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 至 40年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Have a photo ID
  • Body mass index (BMI) <25 kg/m2 and >18 kg/m2
  • Fasting for 8 hours prior to enrollment in the study (a sip of water or brushing teeth in the morning are allowed)
  • Feel well the day of blood donation
  • Normal physical exam and normal blood test as indicated:
  • WBC 4.5-11.0 th/cmm
  • HGB 12.5-17.5 gm/dl
  • PLT 150-400 th/cumm
  • Plasma Sodium 135-145 mmol/L
  • Plasma Potassium 3.4-4.8 mmol/L
  • Plasma Chloride 98-108 mmol/L
  • Plasma Carbon Dioxide 23.0-31.9 mmol/L
  • Plasma Urea Nitrogen 8-25 mg/dl
  • Plasma Creatinine 0.60-1.50 mg/dl
  • Plasma Glucose 70-110 mg/dl
  • Transaminase-SGPT 10-55 U/L
  • Transaminase-SGOT 10-40 U/L

Exclusion Criteria:

  • Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year
  • Systemic disease with or without any functional limitation
  • controlled hypertension
  • controlled diabetes without systemic effects
  • Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin (hCG), or less than six weeks postpartum
  • Active smoking. Volunteers may be enrolled if they quit smoking for more than 1 year
  • Excess alcohol use: more than ½ L/day of wine consumption or equivalent
  • Any current use of a medication other than: Over-the-counter oral medications, herbal remedies, nutritional supplements, and oral contraceptives
  • Antibiotic use within 48 hours of blood donation
  • Use of NSAIDS, corticosteroids, aspirin during the past 7 days
  • Dental work within 24 hours prior to the donation
  • Received or donated blood in the last 4 months
  • Have had any forms of cancer with the exceptions of basal cell skin cancer or treatment for in situ cervical cancer
  • Currently enrolled in another research study

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

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Fresh blood auto-transfusion
Withdrawal from 10 Healthy volunteers of one unit of red blood cells and auto-transfusion after 3 days for one arm of the study, after 40 days for the other. Participants are enrolled in both arms of the study.
实验性的:Old blood auto-transfusion
Withdrawal from 10 Healthy volunteers of one unit of red blood cells and auto-transfusion after 3 days for one arm of the study, after 40 days for the other. Participants are enrolled in both arms of the study.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Endothelial function
大体时间:Baseline
Baseline
Endothelial function
大体时间:10 min after transfusion
10 min after transfusion
Endothelial function
大体时间:1h after transfusion
1h after transfusion
Endothelial function
大体时间:4h after transfusion
4h after transfusion

次要结果测量

结果测量
大体时间
Hemolysis
大体时间:Baseline
Baseline
NO metabolites
大体时间:Baseline
Baseline
Concentration of cytokines
大体时间:Baseline
Baseline
Activation of platelets
大体时间:Baseline
Baseline
Activation of inflammatory lipid mediators
大体时间:Baseline
Baseline
Changes in gene expression
大体时间:Baseline
Baseline
Hemolysis
大体时间:10 min after transfusion
10 min after transfusion
NO metabolites
大体时间:10 min after transfusion
10 min after transfusion
Concentration of cytokines
大体时间:10 min after transfusion
10 min after transfusion
Activation of platelets
大体时间:10 min after transfusion
10 min after transfusion
Activation of inflammatory lipid mediators
大体时间:10 min after transfusion
10 min after transfusion
Changes in gene expression
大体时间:10 min after transfusion
10 min after transfusion
Hemolysis
大体时间:1h after transfusion
1h after transfusion
NO metabolites
大体时间:1h after transfusion
1h after transfusion
Concentration of cytokines
大体时间:1h after transfusion
1h after transfusion
Activation of platelets
大体时间:1h after transfusion
1h after transfusion
Activation of inflammatory lipid mediators
大体时间:1h after transfusion
1h after transfusion
Changes in gene expression
大体时间:1h after transfusion
1h after transfusion
Hemolysis
大体时间:2h after transfusion
2h after transfusion
NO metabolites
大体时间:2h after transfusion
2h after transfusion
Concentration of cytokines
大体时间:2h after transfusion
2h after transfusion
Activation of platelets
大体时间:2h after transfusion
2h after transfusion
Activation of inflammatory lipid mediators
大体时间:2h after transfusion
2h after transfusion
Changes in gene expression
大体时间:2h after transfusion
2h after transfusion
Hemolysis
大体时间:4h after transfusion
4h after transfusion
NO metabolites
大体时间:4h after transfusion
4h after transfusion
Concentration of cytokines
大体时间:4h after transfusion
4h after transfusion
Activation of platelets
大体时间:4h after transfusion
4h after transfusion
Activation of inflammatory lipid mediators
大体时间:4h after transfusion
4h after transfusion
Changes in gene expression
大体时间:4h after transfusion
4h after transfusion

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:Warren M Zapol, MD、Massachusetts General Hospital, DACCPM

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

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

2010年7月1日

初级完成 (实际的)

2010年11月1日

研究完成 (实际的)

2011年2月1日

研究注册日期

首次提交

2010年10月14日

首先提交符合 QC 标准的

2010年10月20日

首次发布 (估计)

2010年10月22日

研究记录更新

最后更新发布 (估计)

2014年1月30日

上次提交的符合 QC 标准的更新

2014年1月29日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

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