Clinical trial NCT01167582: Myocardial Ischemia and Transfusion Pilot
Official title: Myocardial Ischemia and Transfusion Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Unstable Angina
Coronary Artery Disease
Keywords: blood transfusion
red blood cell transfusion
myocardial infarction
acute coronary syndrome
anemia
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Pittsburgh
name: Albert Einstein College of Medicine
name: Brigham and Women's Hospital
name: Rhode Island Hospital
First posted: 2010-07-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hemoglobin Concentration
timeFrame: In-hospital up to 30 days post randomization
measure: Red Blood Cell Transfusion
timeFrame: In-hospital up to 30 days post randomization
Secondary outcomes:
measure: Mortality or Myocardial Ischemia
timeFrame: 30 days
measure: Mortality or Myocardial Ischemia
timeFrame: 6 months
measure: Individual Components of Composite Outcome
timeFrame: 30 days
measure: Mortality From Cardiac Causes
timeFrame: 30 days
measure: Unscheduled Hospital Admission
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
measure: Congestive Heart Failure
timeFrame: 30 days
measure: Stent Thrombosis
timeFrame: 30 days
measure: Deep Vein Thrombosis or Pulmonary Embolism
timeFrame: 30 days
measure: Pneumonia or Blood Stream Infection and Each Separately
timeFrame: 30 days
measure: Composite Mortality and Morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Jack D. Weiler Hospital of Montefiore Medical Center
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Data Coordinating Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Jeffrey L Carson, MD
role: STUDY_CHAIR
affiliation: University of Pittsburgh Data Coordinating Center
name: Sheryl F Kelsey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.