Myocardial Ischemia and Transfusion Pilot

Phase 3

Completed

• Conditions: Coronary Artery Disease; Myocardial Infarction; Unstable Angina
• Interventions: Biological: Red blood cell transfusion

• Registration Number: NCT01167582
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.

Detailed Description

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2014-08-14
• Results First Submitted QC: 2014-08-14
• Results First Posted: 2014-08-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-10
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• age 18 or older;
• STEMI (ST segment elevated myocardial infarction)
• NSTEMI (Non ST segment elevation myocardial infarction)
• unstable angina
• stable coronary artery disease (undergoing cardiac catheterization during the index hospitalization);
• written informed consent has been obtained
• hemoglobin concentration less than 10 g/dL at the time of random allocation.

Exclusion Criteria

• bleeding cannot be controlled at the cardiac catheterization puncture site and/or require surgery to repair vessel
• retroperitoneal bleeding requiring surgery
• clinically important hemodynamic instability based on the judgment of the treating physician
• terminal malignancy or life expectancy less than 6 months
• scheduled for cardiac surgery within the next 30 days
• symptomatic at the time of randomization
• declines blood transfusion
• history of a clinically significant transfusion reaction
• inability to provide informed consent;
• enrolled in a competing study
• previous participation in the MINT trial
• any patient who in the judgment of the research team should not be enrolled in the trial. This would include, but not be limited to, factors such alcohol or drug dependence, or psychiatric illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal Transfusion Strategy	Red blood cell transfusion	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	Red blood cell transfusion	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 Outcome Measures

Name	Time	Method
Hemoglobin Concentration	In-hospital up to 30 days post randomization	Differences in the mean hemoglobin concentrations between the two study arms.
Red Blood Cell Transfusion	In-hospital up to 30 days post randomization	Differences in mean number of units of red blood cell transfusions between the two study arms.

Secondary Outcome Measures

Name	Time	Method
Pneumonia or Blood Stream Infection and Each Separately	30 days
Composite Mortality and Morbidity	30 days	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.
Mortality or Myocardial Ischemia	6 months	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.
Individual Components of Composite Outcome	30 days	All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.
Mortality From Cardiac Causes	30 days
Unscheduled Hospital Admission	30 days	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.
Stent Thrombosis	30 days
Deep Vein Thrombosis or Pulmonary Embolism	30 days
Stroke	30 days
Congestive Heart Failure	30 days

Trial Locations

Locations (7)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh Data Coordinating Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Jack D. Weiler Hospital of Montefiore Medical Center; 🇺🇸 New York, New York, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States