Pilot Study About the Harmful Effects of Blood Storage on Overweight People and the Role of iNO in This Setting

Completed · Phase 2

Conditions studied: Blood Transfusion, Endothelial Physiopathology, Nitric Oxide, Pulmonary Hypertension

In brief

The purpose of this study is to determine whether storage time affects how human body responds to autologous blood transfusion. An autologous blood transfusion is when a person donates blood and then receives that same blood back in the transfusion. We also want to find out if in this situation inhaled nitric oxide can help to prevent the potential reduction of vasodilation capacity. Vasodilation capacity is the ability of the blood vessel to widen when needed.

Key facts

Study ID

NCT01529502

Run by

Massachusetts General Hospital

People needed

14

Starts

2012-03-01

Expected to finish

2013-12-01

Last updated by the study team

2017-05-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a photo ID
• Age>18 years old (required to provide informed consent)
• Age <60 years old
• Mild impairment of endothelial function, assessed by post ischemic vasodilation (L_RHI,<0.7) (38)
• Body mass index (BMI) >27 kg/m\^2 and <40 kg/m\^2
• Fasting during the days of transfusion.
• Avoiding intake of high nitrate food (i.e. green leafy vegetables: lettuce, spinach) on the day prior to the study
• Feel well on the day of blood donation
• KG within normal limits
• Normotensive (systolic blood pressure <140 mmHg and diastolic <90 mmHg)
• Normal physical exam and blood test results as indicated by:
• WBC 4.5-11.0 n x103/μL
• HGB 12.0-17.5 gm/dl
• PLT 150-400 n x103/μL
• 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
• Total Bilirubin < 2 mg/dl
• Fasting plasma glucose < 110 mg/dl

You may not qualify if…

• Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year
• Systemic disease with or without any functional limitation
• 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 uterine cervical cancer
• Currently enrolled in another research study

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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