Effects of Blood Transfusion in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

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

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Detailed Description

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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

Conditions

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Blood Transfusion, Autologous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fresh blood auto-transfusion

Group Type EXPERIMENTAL

Red blood Cells auto-transfusion

Intervention Type PROCEDURE

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.

Old blood auto-transfusion

Group Type EXPERIMENTAL

Red blood Cells auto-transfusion

Intervention Type PROCEDURE

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.

Interventions

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Red blood Cells 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes