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

Mass General Brigham

Status and phase: Withdrawn; Phase 2

Conditions: Hemolysis; Hypertension, Pulmonary

Treatments: Drug: Nitric Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT02217683

BloodiNO

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Young blood transfusion

No Intervention group

Description:

The first group of patients (n=30) will be randomized to receive leukoreduced blood transfusion stored for less than 10 days

Old blood transfusion

No Intervention group

Description:

This randomized group of patients (n=30) will receive leukoreduced blood transfusion stored for more than 30 days

Old blood transfusion and Nitric Oxide

Active Comparator group

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

Treatment:

Drug: Nitric Oxide