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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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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 pulmonary vasoconstriction measured as increase in pulmonary artery pressure and endothelial function measured as a change in reactive hyperemia index in overweight people with existing endothelial dysfunction at baseline.

The present study consists of three different parts, which will be scheduled in a randomized order on the same subject (crossover study).

During one phase of the study, 14 healthy human volunteers will donate a unit of Packed Red Blood Cells (PRBC), which will be leukoreduced and stored in Additive Solutions-1 (AS-1), and then transfused back to the subjects after 3 days of storage at 4º C in the MGH Blood Bank (Fresh Blood arm). The second part of the study consists in the collection of another unit of PRBC from the same volunteers which will be transfused back to them after 40 days of storage (Old Blood arm). Finally in the third part, like in the second one, one unit of PRBC will be withdraw and stored for 40 days, but 80 ppm (parts per million by volume) Nitric Oxide in air will be administered together with the transfusion. There will be a 2 weeks interval after each PRBC transfusion.

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 3 days with the response to PRBC stored for 40 days in the same healthy volunteers. We also want to test the hypothesis that inhaled nitric oxide may reverse these adverse effects.

We will monitor/measure the following parameters:

1. Pulmonary vasoconstriction by trans-thoracic echocardiography
2. Endothelium-mediated changes in vascular (arterial) tone, measured as reactive hyperemia index.

Conditions

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Blood Transfusion Endothelial Physiopathology Nitric Oxide Pulmonary Hypertension

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

Group Type EXPERIMENTAL

Red blood Cells auto-transfusion

Intervention Type PROCEDURE

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.

Old blood

Group Type EXPERIMENTAL

Red blood Cells auto-transfusion

Intervention Type PROCEDURE

Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.

Old blood + inhaled Nitric Oxide

Group Type EXPERIMENTAL

Red blood Cells auto-transfusion

Intervention Type PROCEDURE

Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.

Inhaled Nitric Oxide (iNO) administration

Intervention Type DRUG

Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion.

Interventions

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Red blood Cells auto-transfusion

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.

Intervention Type PROCEDURE

Red blood Cells auto-transfusion

Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.

Intervention Type PROCEDURE

Inhaled Nitric Oxide (iNO) administration

Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Warren M. Zapol

Emeritus Anesthetist-in-Chief and Director of the MGH Anesthesia Center for Critical Care Research, Massachusetts General Hospital; Reginald Jenney Professor of Anesthesia, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR