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NCT01504945 · ClinicalTrials.gov registry record · Phase 1
Red Blood Cell Transfusion in Patients With Coronary Artery Disease (CAD)
A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01504945 is a Phase 1 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 60 participants.
The verdict
NCT01504945, a Phase 1 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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 transfu
Interventions
- OTHER Normal saline infusion
- OTHER RBC transfusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-02 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01504945
The ClinicalTrials.gov registry entry for NCT01504945 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal saline infusion is the first listed.
NCT01504945 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01504945 about?
NCT01504945 is a clinical study titled "Red Blood Cell Transfusion in Patients With Coronary Artery Disease (CAD)". 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 woul...
What is the current status of trial NCT01504945?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-02. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01504945?
The interventions under investigation include: Normal saline infusion (OTHER), RBC transfusion (OTHER).
Who is sponsoring clinical trial NCT01504945?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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