18 and older, any sex, with Myocardial Infarction or Coronary Revascularization. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A Composite Endpoint of All-cause Post-randomization Mortality, Myocardial Infarction (MI), Coronary Revascularization, Acute Renal Failure, or Post-randomization Ischemic Stroke up to 90 Days After RandomizationPrimary· 90 days after randomization
MI will be defined using the Third Universal Definition of Myocardial Infarction. Acute renal failure will be defined as Acute Kidney Injury stage III according to RIFLE criteria. Baseline creatinine will be considered the creatinine upon admission prior to the index operation. The above urine output criteria will be only used for patients who are in the ICU and have precise monitoring of their urinary output. For patients on the surgical floor only serum creatinine changes will be used for assessment of this endpoint. Coronary revascularization will be defined as a coronary artery bypass graf
Group
Value
95% CI
Restrictive
71
Liberal
61
A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and SepsisSecondary· 90 days after randomization
Wound infection will be defined according to the Centers for Disease Control and Prevention (CDC) guidelines as a) positive wound culture, or b) drainage of pus from a wound, or c) suspicion of wound infection that was drained operatively.
Pneumonia will be defined according to the CDC definition as chest radiograph with new or progressive infiltrate, consolidation, cavitation, or pleural effusion and any of the following: new onset of purulent sputum or change in character of sputum, or organism isolated from blood culture, trans-tracheal aspirate, bronchial brushings, or biopsy.
Sepsis wil
Group
Value
95% CI
Restrictive
100
Liberal
103
A Composite Endpoint of Cardiac Complications (Other Than MI) at 90 Days Post-randomization: Cardiac Complications Include New Cardiac Arrhythmias That Necessitate New Treatment, New or Worsening Congestive Heart Failure, and Non Fatal Cardiac ArrestSecondary· 90 days after randomization
The diagnosis of cardiac arrhythmias will be based on EKG findings. Only arrhythmias that result in initiation of new treatment regimen (to include medications, implantable devices, or surgical intervention) during hospitalization will be recorded.
CHF will require at least one of the following symptoms or signs new or worsening: dyspnea at rest, orthopnea, or paroxysmal nocturnal dyspnea and radiological evidence of heart failure or worsening heart failure and increase/initiation of established treatment.
Cardiac arrest will be defined as the cessation of cardiac pump function activity that
Group
Value
95% CI
Restrictive
67
Liberal
38
All-cause Mortality at 1 Year After RandomizationSecondary· 12 months after randomization
The investigators will determine vital status by telephoning participants after hospital discharge, by searching the electronic medical record and the Death Ascertainment File.
Group
Value
95% CI
Restrictive
105
Liberal
94
A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic StrokeSecondary· 30 days after randomization
A composite endpoint of all-cause mortality, MI, coronary revascularization, acute renal failure, or postoperative ischemic stroke.
Group
Value
95% CI
Restrictive
45
Liberal
33
Length of Hospital StaySecondary· At hospital discharge, up to 1 year
Length of hospital stay.
Group
Value
95% CI
Restrictive
5.0
3.0 – 8.0
Liberal
5.0
3.0 – 8.0
Adverse events — posted to ClinicalTrials.gov
Time frame: All SAEs: From randomization until the participant last study active follow up contact (~90 days). All-cause mortality: From randomization up to 12 months post-randomization. Other (not including serious) adverse events: Not collected.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of the proposed study is to determine whether a liberal transfusion strategy (transfusion trigger at Hb \< 10 gm/dl) in Veterans at high cardiac risk who undergo major open vascular and general surgery operations is associated with decreased risk of adverse postoperative outcomes compared to a restrictive transfusion strategy (transfusion trigger at Hb \< 7 gm/dl).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03419780 — SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia
· NA
· completed
NCT03740425 — Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) Study
· completed
NCT00318227 — Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients
· NA
· completed
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Currently open trials in the same condition.
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Other VA Office of Research and Development trials
Trials by the same sponsor.
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· not yet recruiting
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· not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 21 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03229941.