N/A
N=1,424
Transfusion Trigger After Operations in High Cardiac Risk Patients
Myocardial Infarction · Coronary Revascularization · Acute Renal Failure
Bottom Line
View on ClinicalTrials.gov: NCT03229941 ↗Enrolled (actual)
1,424
Serious AEs
53.2%
Results posted
Sep 2025
Primary outcome: Primary: 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 Randomization — 71; 61 Participants — p=0.515
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Transfusion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 Randomization |
71; 61 | 0.515 |
| SECONDARY A Composite Endpoint of Postoperative Infectious Complications at 90 Days Post-randomization: Infectious Complications Will Include Wound Infections, Pneumonia, and Sepsis |
100; 103 | 0.587 |
| SECONDARY 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 Arrest |
67; 38 | 0.007 sig |
| SECONDARY All-cause Mortality at 1 Year After Randomization |
105; 94 | 0.634 |
| SECONDARY A Composite Endpoint of All-cause Mortality, MI, Coronary Revascularization, Acute Renal Failure, or Postoperative Ischemic Stroke |
45; 33 | 0.212 |
| SECONDARY Length of Hospital Stay |
5.0; 5.0 | 0.786 |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Males and females older than 18 years of age who have postoperative Hb 48 hours after the index procedure
- Veteran participating in another interventional trial whose objective is to evaluate the effect of transfusion on outcomes
- Pregnancy in female Veterans
- Veteran is a prisoner or in custody of law enforcement
- Prior randomization in the CSP#599
- Patients who are known to have tested positive for COVID-19 and have not recovered prior to consent will not be consented. Any participant who is known to have a positive COVID-19 test during the screening process and has not recovered will be excluded prior to randomization.
Data sourced from ClinicalTrials.gov (NCT03229941). 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.