Trial Outcomes & Findings for Pilot Study About the Harmful Effects of Blood Storage on Overweight People and the Role of iNO in This Setting (NCT NCT01529502)

Results Overview

Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Post-transfusion

Results posted on

2017-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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).	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).	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).	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).	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).	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).
Overall Study STARTED	2	2	3	3	2	2
Overall Study COMPLETED	2	2	3	1	2	2
Overall Study NOT COMPLETED	0	0	0	2	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fresh Blood-Old Blood-Old Blood + Inhaled Nitric Oxide n=2 Participants 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.	Fresh Blood-Old Blood + Inhaled Nitric Oxide-Old Blood- n=3 Participants 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.	Old Blood- Fresh Blood- Old Blood + Inhaled Nitric Oxide n=3 Participants 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.	Old Blood- Old Blood + Inhaled Nitric Oxide- Fresh Blood n=2 Participants 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.	Old Blood + Inhaled Nitric Oxide- Fresh Blood- Old Blood n=2 Participants 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.	Old Blood + Inhaled Nitric Oxide- Old Blood- Fresh Blood n=2 Participants 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.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	14 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	46 years n=5 Participants	37 years n=7 Participants	46 years n=5 Participants	26.5 years n=4 Participants	51 years n=21 Participants	41 years n=8 Participants	41 years n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	9 Participants n=8 Participants
Region of Enrollment United States	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	2 participants n=8 Participants	14 participants n=8 Participants
Body Mass Index	37 kg/m^2 n=5 Participants	33 kg/m^2 n=7 Participants	30 kg/m^2 n=5 Participants	33.5 kg/m^2 n=4 Participants	35.5 kg/m^2 n=21 Participants	33 kg/m^2 n=8 Participants	33 kg/m^2 n=8 Participants

PRIMARY outcome

Timeframe: Post-transfusion

Population: 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.

Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography

Outcome measures

Outcome measures
Measure	Fresh Blood n=9 Participants 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.	Old Blood n=11 Participants 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.	Old Blood + Inhaled Nitric Oxide n=12 Participants 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.
Systolic Pulmonary Artery Pressure	39 mmHg Standard Error 3	46 mmHg Standard Error 3	31 mmHg Standard Error 2

SECONDARY outcome

Timeframe: Post-transfusion

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.

Outcome measures

Outcome measures
Measure	Fresh Blood n=9 Participants 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.	Old Blood n=11 Participants 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.	Old Blood + Inhaled Nitric Oxide n=12 Participants 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.
Endothelial Function: Reactive Hyperemia Index	0.87 LnRHI Standard Error 0.06	0.9 LnRHI Standard Error 0.06	0.78 LnRHI Standard Error 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: before and after blood transfusion

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.