Status:
COMPLETED
Effects of Blood Transfusion in Healthy Volunteers
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Blood Transfusion, Autologous
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The objective of this study is to assess effects of the storage of PRBC on endothelial function, inflammation and platelet activation in healthy volunteers
Detailed Description
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. D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01226498
Start Date
July 1 2010
End Date
February 1 2011
Last Update
January 30 2014
Active Locations (1)
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1
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114