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

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ClinicalTrials.gov Identifier: NCT01529502
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : March 29, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Warren M. Zapol, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Blood Transfusion
Endothelial Physiopathology
Nitric Oxide
Pulmonary Hypertension
Interventions Procedure: Red blood Cells auto-transfusion
Drug: Inhaled Nitric Oxide (iNO) administration
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fresh Blood - Old Blood - Old Blood+iNO Old Blood - Fresh Blood - Old Blood+iNO Old Blood+iNO - Old Blood - Fresh Blood Fresh Blood - Old Blood+iNO - Old Blood Old Blood - Old Blood+iNO - Fresh Blood Old Blood+iNO - Fresh Blood - Old Blood
Hide Arm/Group Description

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:

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:

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:

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:

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:

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).

Period Title: Overall Study
Started 2 3 2 3 2 2
Completed 2 3 2 1 2 2
Not Completed 0 0 0 2 0 0
Arm/Group Title Fresh Blood-Old Blood-Old Blood + Inhaled Nitric Oxide Fresh Blood-Old Blood + Inhaled Nitric Oxide-Old Blood- Old Blood- Fresh Blood- Old Blood + Inhaled Nitric Oxide Old Blood- Old Blood + Inhaled Nitric Oxide- Fresh Blood Old Blood + Inhaled Nitric Oxide- Fresh Blood- Old Blood Old Blood + Inhaled Nitric Oxide- Old Blood- Fresh Blood Total
Hide Arm/Group Description

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:

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:

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:

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:

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:

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 of all reporting groups
Overall Number of Baseline Participants 2 3 3 2 2 2 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 3 participants 2 participants 2 participants 2 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
3
 100.0%
3
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 3 participants 2 participants 2 participants 2 participants 14 participants
46
(30 to 64)
37
(22 to 46)
46
(34 to 60)
26.5
(26 to 27)
51
(49 to 53)
41
(29 to 53)
41
(22 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 3 participants 2 participants 2 participants 2 participants 14 participants
Female
0
   0.0%
1
  33.3%
1
  33.3%
1
  50.0%
1
  50.0%
1
  50.0%
5
  35.7%
Male
2
 100.0%
2
  66.7%
2
  66.7%
1
  50.0%
1
  50.0%
1
  50.0%
9
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 3 participants 2 participants 2 participants 2 participants 14 participants
2 3 3 2 2 2 14
Body Mass Index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 2 participants 3 participants 3 participants 2 participants 2 participants 2 participants 14 participants
37
(33 to 40)
33
(28 to 37)
30
(28 to 31)
33.5
(32 to 35)
35.5
(31 to 40)
33
(31 to 35)
33
(28 to 40)
1.Primary Outcome
Title Systolic Pulmonary Artery Pressure
Hide Description Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography
Time Frame Post-transfusion
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fresh Blood Old Blood Old Blood + Inhaled Nitric Oxide
Hide Arm/Group Description:
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.
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.

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.

Overall Number of Participants Analyzed 9 11 12
Mean (Standard Error)
Unit of Measure: mmHg
39  (3) 46  (3) 31  (2)
2.Secondary Outcome
Title Endothelial Function: Reactive Hyperemia Index
Hide Description 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.
Time Frame Post-transfusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fresh Blood Old Blood Old Blood + Inhaled Nitric Oxide
Hide Arm/Group Description:
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.
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.

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.

Overall Number of Participants Analyzed 9 11 12
Mean (Standard Error)
Unit of Measure: LnRHI
0.87  (0.06) 0.9  (0.06) 0.78  (0.06)
3.Other Pre-specified Outcome
Title Hemolysis
Hide Description 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.
Time Frame before and after blood transfusion
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Nitric Oxide Metabolites
Hide Description 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.
Time Frame Before and after blood transfusion
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Concentration of Cytokines
Hide Description 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.
Time Frame Before and after blood transfusion
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Activation of Platelets
Hide Description 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.
Time Frame Before and after blood transfusion
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Activation of Inflammatory Lipid Mediators
Hide Description 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.
Time Frame Before and after blood transfusion
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Changes in Gene Expression
Hide Description 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.
Time Frame Before and after blood transfusion
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Endothelial Function
Hide Description 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.
Time Frame Before and after blood transfusion
Outcome Measure Data Not Reported
Time Frame Time over which adverse event data were collected was during blood transfusion up to 1 day after transfusion
Adverse Event Reporting Description 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.
 
Arm/Group Title Fresh Blood Old Blood Old Blood + Inhaled Nitric Oxide
Hide Arm/Group Description 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. 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.

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.

All-Cause Mortality
Fresh Blood Old Blood Old Blood + Inhaled Nitric Oxide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fresh Blood Old Blood Old Blood + Inhaled Nitric Oxide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fresh Blood Old Blood Old Blood + Inhaled Nitric Oxide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/13 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lorenzo Berra
Organization: Massachusetts General Hospital
Phone: 617 724 1901
EMail: LBERRA@MGH.HARVARD.EDU
Layout table for additonal information
Responsible Party: Warren M. Zapol, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01529502     History of Changes
Other Study ID Numbers: Blood Study Overweight
First Submitted: February 6, 2012
First Posted: February 8, 2012
Results First Submitted: October 26, 2016
Results First Posted: March 29, 2017
Last Update Posted: May 22, 2017