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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02217683
Other study ID # BloodiNO
Secondary ID
Status Withdrawn
Phase Phase 2
First received August 13, 2014
Last updated March 16, 2016
Start date March 2016
Est. completion date April 2017

Study information

Verified date March 2016
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Hemolysis Hemolytic markers will be measured such as: haptoglobin, plasma free hemoglobin, hemopexin, and iron metabolites. During and after blood transfusion- average time of observation 6 hours No
Secondary Nitric oxide metabolites Plasma nitric oxide consumption, plasma and red blood cell levels of circulating nitrate, nitrite, nitric will be measured During and after blood transfusion- average time of observation 6 hours No
Secondary Inflammation Inflammation will be assessed by changes of the plasma concentration of cytokines, such as IL-6, IL-8, IL-10, IL-12, TNF, IFN-? During and after blood transfusion- average time of observation 6 hours No
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