Back to resultsUse of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion
Primary Purpose
Hypertension, Pulmonary, Hemolysis
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Catheterization, Swan-Ganz, Cardiac Surgical Procedures, Blood Transfusion, Nitric Oxide
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent
- Elective cardiac or aortic surgery
- One or more blood transfusions scheduled for clinical reasons
- Presence of an arterial catheter and pulmonary arterial catheter
Exclusion Criteria:
- Emergent cardiac surgery.
- Patients requiring irradiated or washed blood transfusions.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Active Comparator
Arm Label
Young blood transfusion
Old blood transfusion
Old blood transfusion and Nitric Oxide
Arm Description
The first group of patients (n=30) will be randomized to receive leukoreduced blood transfusion stored for less than 10 days
This randomized group of patients (n=30) will receive leukoreduced blood transfusion stored for more than 30 days
This randomized group of patients (n=30) will receive leukoreduced blood transfusion stored for more than 30 days while breathing nitric oxide (80 part per million) and oxygen
Outcomes
Primary Outcome Measures
Pulmonary vascular resistance index
Parameters to calculate pulmonary vascular resistance index will be measured during and after blood transfusion for about 6 hours. The following parameters will be recorded: height, weight, systemic pressure, pulmonary pressure, wedge pressure, central venous pressure, cardiac output) of each subjects will be recorded.
Secondary Outcome Measures
Hemolysis
Hemolytic markers will be measured such as: haptoglobin, plasma free hemoglobin, hemopexin, and iron metabolites.
Nitric oxide metabolites
Plasma nitric oxide consumption, plasma and red blood cell levels of circulating nitrate, nitrite, nitric will be measured
Inflammation
Inflammation will be assessed by changes of the plasma concentration of cytokines, such as IL-6, IL-8, IL-10, IL-12, TNF, IFN-γ
Full Information
NCT ID
NCT02217683
First Posted
August 13, 2014
Last Updated
March 16, 2016
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02217683
Brief Title
Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion
Official Title
Pulmonary Hemodynamic Effects of Stored Red Blood Cell Transfusion in Post-Operative Cardiac Surgical Patients: Influence of Breathing Nitric Oxide. A Randomized Controlled Trial in the Cardiac-Intensive Care Unit.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
This trial never started due to lack of funding.
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to assess if prolonged storage time of a packed red blood cell unit may cause pulmonary vasoconstriction after transfusion, in a susceptible population such as cardiac surgery patients. The investigators will also evaluate the potential reversal effect of Inhaled Nitric Oxide on pulmonary vasoconstriction induced by stored blood transfusions.
Detailed Description
Patients will be randomized into one of the three groups:
I. Blood transfusion stored for less than 10 days II. Blood transfusion stored for more than 30 days III. Blood transfusion stored for more than 30 days days plus inhalation of Nitric Oxide at 80 part per million for an hour during blood transfusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary, Hemolysis
Keywords
Catheterization, Swan-Ganz, Cardiac Surgical Procedures, Blood Transfusion, Nitric Oxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Young blood transfusion
Arm Type
No Intervention
Arm Description
The first group of patients (n=30) will be randomized to receive leukoreduced blood transfusion stored for less than 10 days
Arm Title
Old blood transfusion
Arm Type
No Intervention
Arm Description
This randomized group of patients (n=30) will receive leukoreduced blood transfusion stored for more than 30 days
Arm Title
Old blood transfusion and Nitric Oxide
Arm Type
Active Comparator
Arm Description
This randomized group of patients (n=30) will receive leukoreduced blood transfusion stored for more than 30 days while breathing nitric oxide (80 part per million) and oxygen
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Intervention Description
Nitric oxide at 80 part per million will be administrated by inhalation for approximately 1 hour during the blood transfusion
Primary Outcome Measure Information:
Title
Pulmonary vascular resistance index
Description
Parameters to calculate pulmonary vascular resistance index will be measured during and after blood transfusion for about 6 hours. The following parameters will be recorded: height, weight, systemic pressure, pulmonary pressure, wedge pressure, central venous pressure, cardiac output) of each subjects will be recorded.
Time Frame
During and after blood transfusion- average time of observation 6 hours
Secondary Outcome Measure Information:
Title
Hemolysis
Description
Hemolytic markers will be measured such as: haptoglobin, plasma free hemoglobin, hemopexin, and iron metabolites.
Time Frame
During and after blood transfusion- average time of observation 6 hours
Title
Nitric oxide metabolites
Description
Plasma nitric oxide consumption, plasma and red blood cell levels of circulating nitrate, nitrite, nitric will be measured
Time Frame
During and after blood transfusion- average time of observation 6 hours
Title
Inflammation
Description
Inflammation will be assessed by changes of the plasma concentration of cytokines, such as IL-6, IL-8, IL-10, IL-12, TNF, IFN-γ
Time Frame
During and after blood transfusion- average time of observation 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent
Elective cardiac or aortic surgery
One or more blood transfusions scheduled for clinical reasons
Presence of an arterial catheter and pulmonary arterial catheter
Exclusion Criteria:
Emergent cardiac surgery.
Patients requiring irradiated or washed blood transfusions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Berra, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25162920
Citation
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.
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Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion
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