Myocardial Ischemia and Transfusion Pilot

NCT01167582 | Completed Phase 3 Results DMC

• 2 other identifiers: 02200902051RC2HL101458-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Myocardial Infarction; Unstable Angina; Coronary Artery Disease

Keywords

blood transfusion; red blood cell transfusion; myocardial infarction; acute coronary syndrome; anemia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Mortality or Myocardial Ischemia

  30 days

• Mortality or Myocardial Ischemia

  6 months

• Individual Components of Composite Outcome

  30 days

• Mortality From Cardiac Causes

  30 days

• Unscheduled Hospital Admission

  30 days

Study Arms (2)

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.

Biological: Red blood cell transfusion

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.

Biological: Red blood cell transfusion

Interventions

Red blood cell transfusion BIOLOGICAL

Liberal versus restrictive transfusion

Liberal Transfusion Strategy; Restrictive transfusion strategy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Pittsburgh: collaborator
• Albert Einstein College of Medicine: collaborator
• Brigham and Women's Hospital: collaborator
• Rhode Island Hospital: collaborator

Study Sites (7)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Jack D. Weiler Hospital of Montefiore Medical Center

New York, New York, 10461, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461-2301, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Data Coordinating Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

• 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.

  PMID: 23708168 RESULT

• 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.

  PMID: 41114449 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.

  PMID: 34932836 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Angina, Unstable; Coronary Artery Disease; Acute Coronary Syndrome; Anemia

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Limitations and Caveats

This pilot trial was not designed to enroll enough patients to answer the transfusion dilemma currently facing clinicians in practice.

Results Point of Contact

• Title: Jeffrey Carson
• Organization: Rutgers University

jeffrey.carson@rutgers.edu

732-235-7122

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeffrey L Carson

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: July 22, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 20, 2019
• Results First Posted: August 28, 2014

Record last verified: 2019-03

Locations

US (7)