Red Blood Cell Transfusion in Patients With Coronary Artery Disease (CAD)
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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 |
- Endothelial function as measured by flow mediated dilation [ Time Frame: within 1 day of transfusion ] [ Designated as safety issue: Yes ]
- 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 |
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| Contact: Andre Dejam, MD, PhD | adejam@bidmc.harvard.edu | |
| Contact: Duane Pinto, MD | dpinto@caregroup.harvard.edu |
| 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 | |
| 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 May 16, 2013