Phase 3
Completed N=110
Myocardial Ischemia and Transfusion Pilot
Source: ClinicalTrials.gov NCT01167582 ↗Enrolled (actual)
110
Serious AEs
15.6%
Results posted
Aug 2014
Primary outcomePrimary: Hemoglobin Concentration — 10.30; 9.03; 10.78; 8.98 g/dL — p=<0.001
Summary
The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Concentration |
10.30; 9.03; 10.78; 8.98; 10.64; 9.12 | <0.001 sig |
| PRIMARY Red Blood Cell Transfusion |
1.58; 0.49 | <0.001 sig |
| SECONDARY Mortality or Myocardial Ischemia |
15; 20 | — |
| SECONDARY Individual Components of Composite Outcome |
1; 7; 5; 7; 0; 2 | — |
| SECONDARY Mortality From Cardiac Causes |
1; 7 | — |
| SECONDARY Unscheduled Hospital Admission |
9; 17; 3; 8; 0; 2 | — |
| SECONDARY Stroke |
1; 0 | — |
| SECONDARY Congestive Heart Failure |
2; 7 | — |
| SECONDARY Stent Thrombosis |
0; 0 | — |
| SECONDARY Deep Vein Thrombosis or Pulmonary Embolism |
1; 0 | — |
| SECONDARY Pneumonia or Blood Stream Infection and Each Separately |
0; 2; 0; 2; 0; 0 | — |
| SECONDARY Composite Mortality and Morbidity |
6; 16 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01167582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.