Cardiothoracic & vascular anesthesia
Transfusion of Amustaline/Glutathione Pathogen-reduced Red Blood Cells in Cardiac Surgery: A Randomized Phase 3 Clinical Trial
Primary resultResult — go to the resultTreatment difference 0.7% 95% CI −8.9 to 10.4%Authors' conclusion
The incidence of AKI in recipients of pathogen-reduced red cells was noninferior to conventional red cell transfusion.
Study context
- Population
- Cardiac or thoracic-aorta surgery patients with increased risk of red cell transfusion321 (55%) transfused
- Participants
- 581 participants
- Comparison
- Amustaline/glutathione pathogen-reduced vs conventional red cells
- Primary endpoint
- Acute kidney injury (AKI) (increase from baseline ≥0.3 mg/dl serum creatinine)
- Follow-up
- 48 h of surgery
Methodological detailsphase 3, double-blinded, noninferiority
- Phase 3
- Double-blinded
- Noninferiority
Primary result
As reported in the abstract
Treatment difference
0.7%
95% CI −8.9 to 10.4%
P = 0.001 for non-inferiority
Events by treatment group
Pathogen-reduced vs Conventional
treatment difference 0.7% (95% CI −8.9 to 10.4%); P for non-inferiority = 0.001
Further findings
Hemoglobin day 3 nadir · comparable
P = 0.52
AKI by KDIGO criteria · 7 days · not different
P = 0.53
Denominator Pathogen-reduced 159 · Conventional 162
AKI stage III · 7 days
P = 0.075
Denominator Pathogen-reduced 159 · Conventional 162
Safety
| Outcome | Pathogen-reduced |
|---|---|
| Treatment-emergent red cell antibodies (specific, low-titer, no hemolysis) · 75 days | 3.1% |
| Denominator | 159 |
Original publication
Transfusion of Amustaline/Glutathione Pathogen-reduced Red Blood Cells in Cardiac Surgery: A Randomized Phase 3 Clinical Trial. Anesthesiology. Published 12 August 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →