Pilot Study About the Harmful Effects of Blood Storage on Overweight People and the Role of iNO in This Setting
Condition: Blood Transfusion; Endothelial Physiopathology; Nitric Oxide; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Overweight
Intervention: Red blood Cells auto-transfusion; Red blood Cells auto-transfusion; Inhaled Nitric Oxide (iNO) administration
Intervention description: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.; Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.; Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion.
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Blood Transfusion, Autologous; Blood Preservation/adverse effects; Blood Transfusion/adverse effects; Endothelium, Vascular/physiopathology; Hemoglobins; Nitric Oxide; Pulmonary Hypertension

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a photo ID

          2. Age>18 years old (required to provide informed consent)

          3. Age <60 years old

          4. Mild impairment of endothelial function, assessed by post ischemic vasodilation
             (L_RHI,<0.7) (38)

          5. Body mass index (BMI) >27 kg/m^2 and <40 kg/m^2

          6. Fasting during the days of transfusion.

          7. Avoiding intake of high nitrate food (i.e. green leafy vegetables: lettuce, spinach)
             on the day prior to the study

          8. Feel well on the day of blood donation

          9. KG within normal limits

         10. Normotensive (systolic blood pressure <140 mmHg and diastolic <90 mmHg)

         11. Normal physical exam and blood test results as indicated by:

               1. WBC 4.5-11.0 n x103/μL

               2. HGB 12.0-17.5 gm/dl

               3. PLT 150-400 n x103/μL

               4. Plasma Sodium 135-145 mmol/L

               5. Plasma Potassium 3.4-4.8 mmol/L

               6. Plasma Chloride 98-108 mmol/L

               7. Plasma Carbon Dioxide 23.0-31.9 mmol/L

               8. Plasma Urea Nitrogen 8-25 mg/dl

               9. Plasma Creatinine 0.60-1.50 mg/dl

              10. Plasma Glucose 70-110 mg/dl

              11. Transaminase-SGPT 10-55 U/L

              12. Transaminase-SGOT 10-40 U/L

              13. Total Bilirubin < 2 mg/dl

              14. Fasting plasma glucose < 110 mg/dl

              15. Methemoglobin < 3%

        Exclusion Criteria:

          1. Psychiatric disturbances such as anxiety, depression, schizophrenia requiring
             pharmacological treatment or hospitalization in the last year

          2. Systemic disease with or without any functional limitation

          3. Pregnancy determined by urine pregnancy test, detecting presence of human chorionic
             gonadotropin (hCG), or less than six weeks postpartum

          4. Active smoking. Volunteers may be enrolled if they quit smoking for more than 1 year.

          5. Excess alcohol use: more than ½ L/day of wine consumption or equivalent

          6. Any current use of a medication other than: over-the-counter oral medications, herbal
             remedies, nutritional supplements, and oral contraceptives.

          7. Antibiotic use within 48 hours of blood donation

          8. Use of NSAIDS, corticosteroids, aspirin during the past 7 days

          9. Dental work within 24 hours prior to the donation

         10. Received or donated blood in the last 4 months

         11. Have had any forms of cancer with the exceptions of basal cell skin cancer or
             treatment for in situ uterine cervical cancer

         12. Currently enrolled in another research study