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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warren M. Zapol, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01529502
First received: February 6, 2012
Last updated: February 8, 2017
Last verified: February 2017
Results First Received: October 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

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+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).


Participant Flow:   Overall Study
    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
STARTED   2   3   2   3   2   2 
COMPLETED   2   3   2   1   2   2 
NOT COMPLETED   0   0   0   2   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.

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.

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.

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.

Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 2   3   3   2   2   2   14 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Full Range)
 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 
[Units: Participants]
Count of 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 
[Units: Participants]
             
United States   2   3   3   2   2   2   14 
Body Mass Index 
[Units: Kg/m^2]
Mean (Full Range)
 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) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Systolic Pulmonary Artery Pressure   [ Time Frame: Post-transfusion ]

2.  Secondary:   Reactive Hyperemia Index   [ Time Frame: Post-transfusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Lorenzo Berra
Organization: Massachusetts General Hospital
phone: 617 724 1901
e-mail: LBERRA@MGH.HARVARD.EDU


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Warren M. Zapol, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01529502     History of Changes
Other Study ID Numbers: Blood Study Overweight
Study First Received: February 6, 2012
Results First Received: October 26, 2016
Last Updated: February 8, 2017