NCT02217683

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

August 13, 2014

Last Update Submit

March 16, 2016

Conditions

Hypertension, PulmonaryHemolysis

Keywords

Catheterization, Swan-GanzCardiac Surgical ProceduresBlood TransfusionNitric Oxide

Outcome Measures

Primary Outcomes (1)

  • 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.

    During and after blood transfusion- average time of observation 6 hours

Secondary Outcomes (3)

  • Hemolysis

    During and after blood transfusion- average time of observation 6 hours

  • Nitric oxide metabolites

    During and after blood transfusion- average time of observation 6 hours

  • Inflammation

    During and after blood transfusion- average time of observation 6 hours

Study Arms (3)

Young blood transfusion

NO INTERVENTION

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

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

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

Drug: Nitric Oxide

Interventions

Nitric OxideDRUG

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

Old blood transfusion and Nitric Oxide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Emergent cardiac surgery.
  • Patients requiring irradiated or washed blood transfusions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 25162920BACKGROUND

MeSH Terms

Conditions

Hypertension, PulmonaryHemolysis

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic Chemicals

Study Officials

  • Lorenzo Berra, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff anesthesiologist

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

March 18, 2016

Record last verified: 2016-03

Locations

US(1)