Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion

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.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02217683

Enrollment

Registered

2014-08-15

Start date

2016-03-31

Completion date

2017-04-30

Last updated

2016-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemolysis, Hypertension, Pulmonary

Keywords

Catheterization, Swan-Ganz, Cardiac Surgical Procedures, Blood Transfusion, Nitric Oxide

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.

Interventions

DRUGNitric Oxide

Nitric oxide at 80 part per million will be administrated by inhalation for approximately 1 hour during the blood transfusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Provide written informed consent 2. Elective cardiac or aortic surgery 3. One or more blood transfusions scheduled for clinical reasons 4. Presence of an arterial catheter and pulmonary arterial catheter

Exclusion criteria

1. Emergent cardiac surgery. 2. Patients requiring irradiated or washed blood transfusions.

Design outcomes

Primary

Measure	Time frame	Description
Pulmonary vascular resistance index	During and after blood transfusion- average time of observation 6 hours	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

Measure	Time frame	Description
Hemolysis	During and after blood transfusion- average time of observation 6 hours	Hemolytic markers will be measured such as: haptoglobin, plasma free hemoglobin, hemopexin, and iron metabolites.
Nitric oxide metabolites	During and after blood transfusion- average time of observation 6 hours	Plasma nitric oxide consumption, plasma and red blood cell levels of circulating nitrate, nitrite, nitric will be measured
Inflammation	During and after blood transfusion- average time of observation 6 hours	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026