Myocardial Ischemia and Transfusion Pilot (MINT Pilot)

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease; Unstable Angina; Myocardial Infarction

Treatments: Biological: Red blood cell transfusion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01167582

0220090205

1RC2HL101458-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 2 patient groups

Liberal Transfusion Strategy

Experimental group

Description:

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.

Treatment:

Biological: Red blood cell transfusion

Restrictive transfusion strategy

Experimental group

Description:

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.

Treatment:

Biological: Red blood cell transfusion