Status:
COMPLETED
Storage Lesion in Banked Blood Due to Disruption of Nitric Oxide (NO) Homeostasis
Lead Sponsor:
Mark Gladwin
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to explore the impact of aged blood on endothelial function by measuring forearm blood flow during intra-arterial acetylcholine infusion in normal healthy human volunteers...
Detailed Description
The increased storage time of transfused blood is associated with an increased risk of cardiovascular events and organ failure. The underlying biological mechanism as to why this happens is not unders...
Eligibility Criteria
Inclusion
- Male or female and 18 to 50 years of age.
- Able to read and comprehend the English language
Exclusion
- Less than 18 or greater than 50 years of age.
- Female \< 110 lbs or 50 kg
- Male \< 110 lbs or 50 kg
- Hemoglobin \<12.5g/dl
- Past medical history or symptoms of blood dyscrasia, diabetes mellitus, hyperlipidemia, obstructive sleep apnea, hypertension, significant cardiac disease and / or known peripheral arterial disease.
- History of cigarette smoking within the last month
- Serum creatinine \>1.0 mg/dL
- Cognitively impaired subjects, or institutionalized persons and subjects unable or unwilling to complete written informed consent (no proxy consent will be obtained)
- Subjects with a history of blood donation within the last 60 days.
- Subjects who have performed other medical studies involving drug delivery in the last 30 days.
- Subjects with an oxygen saturation value \< 92%.
- Any STATIN drug (Fluvastatin, Lovastatin, Pravastatin, Simvastatin, Rosuvastatin) currently or in the 4 weeks prior to the screening day
- Any medication for the treatment of diabetes including oral hypoglycemics or insulin
- lab tests indicating blood dyscrasia, diabetes, hypertension or hypercholesterolemia.Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on screening day will be excluded
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01137656
Start Date
April 1 2010
End Date
September 1 2013
Last Update
April 14 2015
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213