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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension, Pulmonary Hemolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Young blood transfusion

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Old blood transfusion

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Old blood transfusion and Nitric Oxide

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

Group Type ACTIVE_COMPARATOR

Nitric Oxide

Intervention Type DRUG

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

Interventions

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Nitric Oxide

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

Intervention Type DRUG

Eligibility Criteria

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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