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Red Blood Cell Transfusion in Patients With Coronary Artery Disease (CAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504945
Recruitment Status : Terminated (Recruitment difficulty)
First Posted : January 6, 2012
Last Update Posted : February 23, 2018
American Heart Association
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Brief Summary:

Patients with a low blood count (anemia) with stable or unstable coronary artery disease consistently show worse clinical outcomes. It is unclear whether this association is confounded since anemic patients tend to be also sicker i.e. have lower ejection fractions or more comorbidities and this would be the reason for the worse outcomes rather than anemia. The coronary arteries are a unique vascular bed insofar that across the cardiac circulation oxygen extraction is close to maximal at rest. Thus increases in demand can only be met by increases in blood flow and hemoglobin concentration since oxygen extraction is maximal at rest. It is natural to assume that maximization of oxygen delivery in the setting of active coronary syndrome (ACS) is beneficial to the patient since oxygen extraction and coronary blood flow is fixed. In fact, in most intensive care units patients with ACS are transfused to a HCT of 30%. However, retrospective analysis of trial data showed at best mixed results in clinical outcome when patients with ACS were transfused and in fact in some studies showed consistently worse outcomes than non-transfused patients. Similar disappointing results have recently published in patient who underwent coronary artery bypass grafting (CABG).

This study is designed to determine the effect of red blood cell (RBC) transfusion on oxygen consumption, cardiac, microcirculatory and endothelial function in patients with active coronary artery disease. For this study active coronary artery disease will be defined as the patient having undergone within the past 4 days of recruitment either a myocardial infarction due to atherothrombosis (AHA type I myocardial infarction) or surgery for coronary artery bypass grafting.

In specific this study will test the hypothesis whether RBC transfusions improves cardiac and vascular function in patients with a hematocrit of less than 30% with active coronary artery disease.

Aims of this study are to determine whether RBC transfusion in patients with active coronary artery disease and anemia:

  • increases oxygen delivery to the peripheral tissues.
  • increases whole-body oxygen consumption.
  • decreases nitric oxide bioavailability, endothelial, microcirculatory, and myocardial function, and/or increases platelet aggregation

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Anemia Other: RBC transfusion Other: Normal saline infusion Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Red Blood Cell Transfusion in Patients With Acute and Chronic Coronary Syndrome
Study Start Date : February 2010
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: RBC transfusion Other: RBC transfusion
1 bag of packed red blood cells

Placebo Comparator: Normal saline infusion Other: Normal saline infusion
500 mL of normal saline infusion

Primary Outcome Measures :
  1. Endothelial function as measured by flow mediated dilation [ Time Frame: within 1 day of transfusion ]

Secondary Outcome Measures :
  1. platelet function [ Time Frame: within one hour of transfusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ACS as defined by a patient who has cardiac chest discomfort and a troponin (cTnT) elevation of greater than 0.1 ng/mL.
  • Pt. who is s/p CABG
  • Patients with chronic coronary artery disease will be recruited as defined as past history of myocardial infarction, percutaneous coronary intervention, CABG, or history of coronary artery disease documented in the medical record.
  • Anemia as defined by HCT between 21%-30%.

Exclusion Criteria:

  • Patients with stage III/IV heart failure
  • Patients who are actively bleeding requiring immediate transfusion.
  • Pregnant patients will be excluded.
  • Patients taking sildenafil (Viagra) or other drugs like it, such as vardenafil (Levitra), or tadalafil (Cialis) within 48 hours before the study.
  • Patients on iv nitroglycerine infusion.
  • Patients who present with ACS or CABG surgery and who are hemodynamically unstable or require immediate revascularization.
  • Patients who have received a blood transfusion 24 hours prior to the start of the study.
  • Patients with a HCT of < 21% and those that have chest tube drainage greater then 30 mL/h will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01504945

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
American Heart Association
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Principal Investigator: Andre Dejam, MD, PhD Beth Israel Deaconess Medical Center
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Responsible Party: Michael Donnino, Associate Professor of Emergency Medicine, Beth Israel Deaconess Medical Center Identifier: NCT01504945    
Other Study ID Numbers: 2009P000436
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Keywords provided by Michael Donnino, Beth Israel Deaconess Medical Center:
chronic coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases