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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh blood | Experimental |
| |
| Old blood | Experimental |
| |
| Old blood + inhaled Nitric Oxide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood Cells auto-transfusion | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Pulmonary Artery Pressure | Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography | Post-transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function: Reactive Hyperemia Index | Reactive Hyperemia Index (RHI) measures Endothelial function and is assessed by digital pulse amplitude tonometry and it is a sensitive indicator of endothelial function. RHI is a calculated as a ratio between tested versus contralateral finger dilatation, thus there is no unit measure. | Post-transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Hemolysis | To assess concentration of plasma Hemoglobin at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | before and after blood transfusion |
| Nitric Oxide Metabolites |
Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Zapol, MD | Masachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19224780 | Background | Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e. | |
| 18354101 | Background | Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fresh Blood - Old Blood - Old Blood+iNO | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Red blood Cells auto-transfusion | 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 | Drug | Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion. |
|
To assess concentration of plasma Nitric oxide metabolites at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. |
| Before and after blood transfusion |
| Concentration of Cytokines | To assess concentration of plasma cytokines at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Before and after blood transfusion |
| Activation of Platelets | To assess concentration of plasma activation of platelets at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Before and after blood transfusion |
| Activation of Inflammatory Lipid Mediators | To assess concentration of plasma activation of inflammatory lipid mediators at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Before and after blood transfusion |
| Changes in Gene Expression | To assess concentration of changes in gene expression at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Before and after blood transfusion |
| Endothelial Function | To assess Endothelial function by RHI at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Before and after blood transfusion |
| 17940021 | Background | Bennett-Guerrero E, Veldman TH, Doctor A, Telen MJ, Ortel TL, Reid TS, Mulherin MA, Zhu H, Buck RD, Califf RM, McMahon TJ. Evolution of adverse changes in stored RBCs. Proc Natl Acad Sci U S A. 2007 Oct 23;104(43):17063-8. doi: 10.1073/pnas.0708160104. Epub 2007 Oct 11. |
| 10856270 | Background | Cardillo C, Kilcoyne CM, Cannon RO 3rd, Panza JA. Interactions between nitric oxide and endothelin in the regulation of vascular tone of human resistance vessels in vivo. Hypertension. 2000 Jun;35(6):1237-41. doi: 10.1161/01.hyp.35.6.1237. |
| 8491001 | Background | Panza JA, Casino PR, Kilcoyne CM, Quyyumi AA. Role of endothelium-derived nitric oxide in the abnormal endothelium-dependent vascular relaxation of patients with essential hypertension. Circulation. 1993 May;87(5):1468-74. doi: 10.1161/01.cir.87.5.1468. |
| 22021369 | Background | Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20. |
| 25162920 | Derived | Berra L, Pinciroli R, Stowell CP, Wang L, Yu B, Fernandez BO, Feelisch M, Mietto C, Hod EA, Chipman D, Scherrer-Crosbie M, Bloch KD, Zapol WM. Autologous transfusion of stored red blood cells increases pulmonary artery pressure. Am J Respir Crit Care Med. 2014 Oct 1;190(7):800-7. doi: 10.1164/rccm.201405-0850OC. |
| FG001 | Old Blood - Fresh Blood - Old Blood+iNO | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO). |
| FG002 | Old Blood+iNO - Old Blood - Fresh Blood | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO). |
| FG003 | Fresh Blood - Old Blood+iNO - Old Blood | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO). |
| FG004 | Old Blood - Old Blood+iNO - Fresh Blood | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO). |
| FG005 | Old Blood+iNO - Fresh Blood - Old Blood | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fresh Blood-Old Blood-Old Blood + Inhaled Nitric Oxide | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. 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. |
| BG001 | Fresh Blood-Old Blood + Inhaled Nitric Oxide-Old Blood- | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. 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. |
| BG002 | Old Blood- Fresh Blood- Old Blood + Inhaled Nitric Oxide | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. 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. |
| BG003 | Old Blood- Old Blood + Inhaled Nitric Oxide- Fresh Blood | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. 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. |
| BG004 | Old Blood + Inhaled Nitric Oxide- Fresh Blood- Old Blood | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. 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. |
| BG005 | Old Blood + Inhaled Nitric Oxide- Old Blood- Fresh Blood | FRESH BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. OLD BLOOD: Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time. 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Full Range | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Pulmonary Artery Pressure | Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography | In the "fresh blood" only 9 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully studied by trans-thoracic echocardiography. In the "old blood" only 11 volunteers and In the "old blood + Inhaled Nitric Oxide" only 12 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully evaluated. | Posted | Mean | Standard Error | mmHg | Post-transfusion |
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| Secondary | Endothelial Function: Reactive Hyperemia Index | Reactive Hyperemia Index (RHI) measures Endothelial function and is assessed by digital pulse amplitude tonometry and it is a sensitive indicator of endothelial function. RHI is a calculated as a ratio between tested versus contralateral finger dilatation, thus there is no unit measure. | Posted | Mean | Standard Error | LnRHI | Post-transfusion |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hemolysis | To assess concentration of plasma Hemoglobin at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Not Posted | before and after blood transfusion | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Nitric Oxide Metabolites | To assess concentration of plasma Nitric oxide metabolites at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Not Posted | Before and after blood transfusion | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Concentration of Cytokines | To assess concentration of plasma cytokines at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Not Posted | Before and after blood transfusion | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Activation of Platelets | To assess concentration of plasma activation of platelets at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Not Posted | Before and after blood transfusion | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Activation of Inflammatory Lipid Mediators | To assess concentration of plasma activation of inflammatory lipid mediators at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Not Posted | Before and after blood transfusion | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Changes in Gene Expression | To assess concentration of changes in gene expression at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Not Posted | Before and after blood transfusion | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Endothelial Function | To assess Endothelial function by RHI at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion. | Not Posted | Before and after blood transfusion | Participants |
Time over which adverse event data were collected was during blood transfusion up to 1 day after transfusion
14 volunteers were enrolled in the study and received the "Fresh Blood". Two of the 14 volunteers left the study before finishing all three arms. One of the two of the volunteers that left the study, completed the "Fresh Blood" and "Old Blood", thus 13 volunteers completed the "Old Blood" arm. The last volunteer left before receiving "Old Blood + Inhaled Nitric Oxide", thus the number of participants in and the the "Old Blood + Inhaled Nitric Oxide" arm is twelve.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fresh Blood | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Old Blood | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Old Blood + Inhaled Nitric Oxide | 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. 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lorenzo Berra | Massachusetts General Hospital | 617 724 1901 | LBERRA@MGH.HARVARD.EDU |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007288 | Inosine |
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D006298 | Health Services Administration |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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|