Myocardial Ischemia and Transfusion Pilot

NCT ID: NCT01167582

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

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.

Conditions

Myocardial Infarction; Unstable Angina; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Red blood cell transfusion

Intervention Type: BIOLOGICAL

Liberal versus restrictive transfusion

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.

Group Type: EXPERIMENTAL

Red blood cell transfusion

Intervention Type: BIOLOGICAL

Liberal versus restrictive transfusion

Interventions

Red blood cell transfusion

Liberal versus restrictive transfusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey L Carson, MD

Jeffrey L Carson

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey L Carson, MD

Role: STUDY_CHAIR

Rutgers, The State University of New Jersey

Sheryl F Kelsey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Data Coordinating Center

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Jack D. Weiler Hospital of Montefiore Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Data Coordinating Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23708168 (View on PubMed)

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:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type: DERIVED

PMID: 41114449 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34932836 (View on PubMed)

Other Identifiers

1RC2HL101458-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0220090205

Identifier Type: -

Identifier Source: org_study_id