Acute cardiac care & resuscitationRandomised controlled trial
Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery
- Randomised controlled trial
- unblinded
- non-inferiority
- multicentre (12 hospitals, Canada and US)
Authors' conclusion
In this unblinded randomized clinical trial, PCC had superior hemostatic efficacy and safety advantages to frozen plasma among patients requiring coagulation factor replacement for bleeding during cardiac surgery.
Study context
- Population
- Adults undergoing cardiac surgery with bleeding related to coagulation factor deficiency after termination of cardiopulmonary bypass420 in primary analysis
- Participants
- 538 adults
- Comparison
- 4-factor prothrombin complex concentrate (PCC) vs frozen plasma
- PCCn = 265
- Frozen plasman = 263reference
- Primary endpoint
- Hemostatic response (effective if no hemostatic interventions from 60 min to 24 h after treatment initiation)
- Follow-up
- 24 hours
Primary result
Hemostatic effectiveness
Difference
17.6%
95% CI 8.7%–26.4%
P < 0.001
Events by treatment group
PCC vs Frozen plasma
difference 17.6% (95% CI 8.7%–26.4%); P < 0.001
Non-inferiority margin 10 as printed, not drawn
As reported in the abstract
Secondary outcomes
| Outcome | PCC | Frozen plasma | difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Transfusions (RBC, platelets, noninvestigational frozen plasma units) · fewer with PCC | mean 6.6 (95% CI 5.7–7.7) units | mean 9.3 (95% CI 8.0–10.8) units | 2.7 (1.0–4.4) | P = 0.002 | |
| −20246Difference (linear scale) |
Safety
| Outcome | PCC | Frozen plasma | RR (95% CI) | P value | |
|---|---|---|---|---|---|
| Serious adverse events | 36.2% | 47.3% | 0.76 (0.61–0.96) | P = 0.02 | |
| AKI | 10.3% | 18.8% | 0.55 (0.34–0.89) | P = 0.02 | |
| 0.20.5125Relative risk (log scale) |
Original publication
Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery. JAMA. Published 27 May 2025. doi:10.1001/jama.2025.3501
Summarised from the published abstract; every number is checked against it