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

Phase 2

Withdrawn

• Conditions: Hypertension, Pulmonary; Hemolysis
• Interventions: Drug: Nitric Oxide

• Registration Number: NCT02217683
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Status Verified: 2016-03
• Study Start: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-18
• Primary Completion: 2016-12
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Old blood transfusion and Nitric Oxide	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States