Effects of Blood Transfusion in Healthy Volunteers
Effects of Duration of Stored Red Blood Cell Transfusion on Physiological Parameters and Inflammatory Mediators in Healthy Adult Volunteers
研究概览
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:
- Endothelium-mediated changes in vascular (arterial) tone
- Tissue oxygen saturation will be continuously assessed during and after blood transfusion
- Hemolysis as quantified by changes in plasma haptoglobin level, plasma free hemoglobin, LDH level, bilirubin level, iron level, ferritin, and transferrin
- Changes of plasma and red blood cell levels of circulating nitrate, nitrite, RXNO, RNNO, NO-heme
- Concentration of cytokines, such as IL-6, IL-8, IL-10, IL-12, TNF, IFN-γ
- Activation of platelets through circulating P-selectin expression on platelets
- Activation of inflammatory lipid mediators
- Changes in gene expression profiling analyzing RNA microarray of circulating leukocytes
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital (MGH)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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实验性的:Fresh blood auto-transfusion
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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.
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实验性的:Old blood auto-transfusion
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Endothelial function
大体时间:Baseline
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Baseline
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Endothelial function
大体时间:10 min after transfusion
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10 min after transfusion
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Endothelial function
大体时间:1h after transfusion
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1h after transfusion
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Endothelial function
大体时间:4h after transfusion
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4h after transfusion
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Hemolysis
大体时间:Baseline
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Baseline
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NO metabolites
大体时间:Baseline
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Baseline
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Concentration of cytokines
大体时间:Baseline
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Baseline
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Activation of platelets
大体时间:Baseline
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Baseline
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Activation of inflammatory lipid mediators
大体时间:Baseline
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Baseline
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Changes in gene expression
大体时间:Baseline
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Baseline
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Hemolysis
大体时间:10 min after transfusion
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10 min after transfusion
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NO metabolites
大体时间:10 min after transfusion
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10 min after transfusion
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Concentration of cytokines
大体时间:10 min after transfusion
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10 min after transfusion
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Activation of platelets
大体时间:10 min after transfusion
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10 min after transfusion
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Activation of inflammatory lipid mediators
大体时间:10 min after transfusion
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10 min after transfusion
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Changes in gene expression
大体时间:10 min after transfusion
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10 min after transfusion
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Hemolysis
大体时间:1h after transfusion
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1h after transfusion
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NO metabolites
大体时间:1h after transfusion
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1h after transfusion
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Concentration of cytokines
大体时间:1h after transfusion
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1h after transfusion
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Activation of platelets
大体时间:1h after transfusion
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1h after transfusion
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Activation of inflammatory lipid mediators
大体时间:1h after transfusion
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1h after transfusion
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Changes in gene expression
大体时间:1h after transfusion
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1h after transfusion
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Hemolysis
大体时间:2h after transfusion
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2h after transfusion
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NO metabolites
大体时间:2h after transfusion
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2h after transfusion
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Concentration of cytokines
大体时间:2h after transfusion
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2h after transfusion
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Activation of platelets
大体时间:2h after transfusion
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2h after transfusion
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Activation of inflammatory lipid mediators
大体时间:2h after transfusion
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2h after transfusion
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Changes in gene expression
大体时间:2h after transfusion
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2h after transfusion
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Hemolysis
大体时间:4h after transfusion
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4h after transfusion
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NO metabolites
大体时间:4h after transfusion
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4h after transfusion
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Concentration of cytokines
大体时间:4h after transfusion
|
4h after transfusion
|
|
Activation of platelets
大体时间:4h after transfusion
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4h after transfusion
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|
Activation of inflammatory lipid mediators
大体时间:4h after transfusion
|
4h after transfusion
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Changes in gene expression
大体时间:4h after transfusion
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4h after transfusion
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合作者和调查者
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
一般刊物
- Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.
- Gladwin MT, Lancaster JR Jr, Freeman BA, Schechter AN. Nitric oxide's reactions with hemoglobin: a view through the SNO-storm. Nat Med. 2003 May;9(5):496-500. doi: 10.1038/nm0503-496. No abstract available.
- Panza JA, Casino PR, Kilcoyne CM, Quyyumi AA. Role of endothelium-derived nitric oxide in the abnormal endothelium-dependent vascular relaxation of patients with essential hypertension. Circulation. 1993 May;87(5):1468-74. doi: 10.1161/01.cir.87.5.1468.
- Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.
- Bennett-Guerrero E, Veldman TH, Doctor A, Telen MJ, Ortel TL, Reid TS, Mulherin MA, Zhu H, Buck RD, Califf RM, McMahon TJ. Evolution of adverse changes in stored RBCs. Proc Natl Acad Sci U S A. 2007 Oct 23;104(43):17063-8. doi: 10.1073/pnas.0708160104. Epub 2007 Oct 11.
- Cardillo C, Kilcoyne CM, Cannon RO 3rd, Panza JA. Interactions between nitric oxide and endothelin in the regulation of vascular tone of human resistance vessels in vivo. Hypertension. 2000 Jun;35(6):1237-41. doi: 10.1161/01.hyp.35.6.1237.
- Nagasaka Y, Fernandez BO, Garcia-Saura MF, Petersen B, Ichinose F, Bloch KD, Feelisch M, Zapol WM. Brief periods of nitric oxide inhalation protect against myocardial ischemia-reperfusion injury. Anesthesiology. 2008 Oct;109(4):675-82. doi: 10.1097/ALN.0b013e318186316e.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2010P000961
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