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

NCT01504945 | Terminated Phase 1 DMC

• 1 other identifier: 2009P000436
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Coronary Syndrome; Anemia

Keywords

chronic coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Endothelial function as measured by flow mediated dilation

  within 1 day of transfusion

Secondary Outcomes (1)

• platelet function

  within one hour of transfusion

Study Arms (2)

RBC transfusion

ACTIVE COMPARATOR

Other: RBC transfusion

Normal saline infusion

PLACEBO COMPARATOR

Other: Normal saline infusion

Interventions

RBC transfusion OTHER

1 bag of packed red blood cells

RBC transfusion

Normal saline infusion OTHER

500 mL of normal saline infusion

Normal saline infusion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Anemia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Andre Dejam, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: January 6, 2012
• Study Start: February 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (1)