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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC2HL101458-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Pittsburgh | OTHER |
| Albert Einstein College of Medicine | OTHER |
| Brigham and Women's Hospital |
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The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.
Red blood cell transfusions are extremely common medical interventions, yet, it remains unclear when patients should be transfused. This pilot study will evaluate the feasibility of conducting a research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of two transfusion threshold strategies in patients with coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal Transfusion Strategy | Experimental | Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL. |
|
| Restrictive transfusion strategy | Experimental | Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL. Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cell transfusion | Biological | Liberal versus restrictive transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentration | Differences in the mean hemoglobin concentrations between the two study arms. | In-hospital up to 30 days post randomization |
| Red Blood Cell Transfusion | Differences in mean number of units of red blood cell transfusions between the two study arms. | In-hospital up to 30 days post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality or Myocardial Ischemia | Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days. | 30 days |
| Mortality or Myocardial Ischemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Carson, MD | Rutgers, The State University of New Jersey | Study Chair |
| Sheryl F Kelsey, PhD | University of Pittsburgh Data Coordinating Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States | ||
| Robert Wood Johnson University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23708168 | Result | Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8. | |
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liberal Transfusion Strategy | Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL. |
| FG001 | Restrictive Transfusion Strategy | Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL. Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Liberal Transfusion Strategy | Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin Concentration | Differences in the mean hemoglobin concentrations between the two study arms. | Posted | Mean | Standard Deviation | g/dL | In-hospital up to 30 days post randomization |
|
Up to 6 months following randomization
Obtained via telephone follow-up and, if relevant, medical record review
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liberal Transfusion Strategy | Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death at 6 months | Cardiac disorders | Systematic Assessment |
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This pilot trial was not designed to enroll enough patients to answer the transfusion dilemma currently facing clinicians in practice.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Carson | Rutgers University | 732-235-7122 | jeffrey.carson@rutgers.edu |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000789 | Angina, Unstable |
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| OTHER |
| Rhode Island Hospital | OTHER |
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Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months. |
| 6 months |
| Individual Components of Composite Outcome | All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization. | 30 days |
| Mortality From Cardiac Causes | 30 days |
| Unscheduled Hospital Admission | Unscheduled hospital admission at 30 days for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection. | 30 days |
| Stroke | 30 days |
| Congestive Heart Failure | 30 days |
| Stent Thrombosis | 30 days |
| Deep Vein Thrombosis or Pulmonary Embolism | 30 days |
| Pneumonia or Blood Stream Infection and Each Separately | 30 days |
| Composite Mortality and Morbidity | Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization or pneumonia. | 30 days |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| Jack D. Weiler Hospital of Montefiore Medical Center | New York | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461-2301 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Data Coordinating Center | Pittsburgh | Pennsylvania | 15261 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| 34932836 | Derived | Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5. |
| BG001 | Restrictive Transfusion Strategy | Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL. Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.
Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension.
|
|
|
| Primary | Red Blood Cell Transfusion | Differences in mean number of units of red blood cell transfusions between the two study arms. | Posted | Mean | Standard Deviation | blood units | In-hospital up to 30 days post randomization |
|
|
|
|
| Secondary | Mortality or Myocardial Ischemia | Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days. | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Mortality or Myocardial Ischemia | Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | Individual Components of Composite Outcome | All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization. | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | Mortality From Cardiac Causes | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Unscheduled Hospital Admission | Unscheduled hospital admission at 30 days for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Stroke | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Congestive Heart Failure | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Stent Thrombosis | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Deep Vein Thrombosis or Pulmonary Embolism | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Pneumonia or Blood Stream Infection and Each Separately | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Composite Mortality and Morbidity | Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization or pneumonia. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 7 |
| 55 |
| 0 |
| 55 |
| EG001 | Restrictive Transfusion Strategy | Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL. Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension. | 10 | 54 | 0 | 54 |
| Myocardial Infarction at 30 days | Cardiac disorders | Systematic Assessment |
|
| Congestive Heart Failure at 30 Days | Cardiac disorders | Systematic Assessment |
|
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| Unscheduled Coronary Revascularization |
|
| Risk Ratio (RR) |
| 1.43 |
| 2-Sided |
| 95 |
| 0.48 |
| 4.22 |
Restrictive Arm (numerator) compared to Liberal Arm (denominator) |
| Superiority or Other |
| Infection Readmission |
|
| Blood Stream Infection |
|