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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01504945
First received: April 25, 2011
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Anemia
Other: RBC transfusion
Other: Normal saline infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Red Blood Cell Transfusion in Patients With Acute and Chronic Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Endothelial function as measured by flow mediated dilation [ Time Frame: within 1 day of transfusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • platelet function [ Time Frame: within one hour of transfusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504945

Contacts
Contact: Andre Dejam, MD, PhD adejam@bidmc.harvard.edu
Contact: Duane Pinto, MD dpinto@caregroup.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Andre Dejam, MD, PhD       adejam@bidmc.harvard.edu   
Contact: Duane Pinto, MD       dpinto@caregroup.harvard.edu   
Sub-Investigator: Andre Dejam, MD, PhD         
Principal Investigator: Duane Pinto, MD         
Sub-Investigator: Michael Donnino, MD         
Sub-Investigator: Tyler Giberson, MS         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
American Heart Association
Investigators
Principal Investigator: Andre Dejam, MD, PhD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01504945     History of Changes
Other Study ID Numbers: 2009P-000436
Study First Received: April 25, 2011
Last Updated: January 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
chronic coronary artery disease

Additional relevant MeSH terms:
Anemia
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Hematologic Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014