Vitamin K Antagonist Reversal for Urgent Surgery Using 4-Factor Prothrombin Complex Concentrates: A Randomized Clinical Trial
Primary result · Effective hemostasisResult — go to the resultProportion difference 0.001 95% CI −0.080 to 0.082Authors' conclusion
This randomized clinical trial found that the investigational 4F-PCC was hemostatically noninferior to the control 4F-PCC for rapid VKA reversal in patients needing urgent surgery with considerable bleeding risk; the safety profile of these two 4F-PCCs was similar.
Study context
- Population
- Adults taking VKA with international normalized ratio (INR) ≥2 needing urgent surgery with substantial bleeding risk (≥50 mL)
- Participants
- 208 adults
- Comparison
- Investigational 4F-PCC vs control 4F-PCC
- Investigationaln = 105
- Controln = 103reference
- Primary endpoint
- Hemostatic efficacy (objective 4-point scale, blinded independent adjudication board)
- Follow-up
- Surgery end
Methodological detailsphase 3, double-blind, non-inferiority, multicentre (24 hospitals), 24 hospitals in the US, Russia, Georgia, Belarus, Ukraine, and Romania, June 7, 2017–November 8, 2021; study stopped February 2022
- Phase 3
- Double-blind
- Non-inferiority
- Multicentre (24 hospitals)
- 24 hospitals in the US, Russia, Georgia, Belarus, Ukraine, and Romania, June 7, 2017–November 8, 2021; study stopped February 2022
Primary result
Effective hemostasis
Proportion difference
0.001
95% CI −0.080 to 0.082
P < 0.001
By group
Investigational vs Control
proportion difference 0.001 (95% CI −0.080 to 0.082); P < 0.001
As reported in the abstract
Further findings
| Outcome | Investigational | Control | Proportion difference (95% CI) | |
|---|---|---|---|---|
| INR ≤1.5 · 30 minutes after infusion | 78.1% | 71.8% | 0.063 (−0.056 to 0.181) | |
| −0.100.10.2Difference (linear scale) |
Mortality
Mortality
- No different than expected for 4F-PCC use
Safety
Thrombotic events
Events
| Outcome | Investigational | Control |
|---|---|---|
| Discontinuation due to adverse events | 1 | 1 |
- Discontinuation due to adverse events: cardiac disorders unrelated to 4F-PCC
Thrombotic events
- No different than expected for 4F-PCC use
Original publication
Vitamin K Antagonist Reversal for Urgent Surgery Using 4-Factor Prothrombin Complex Concentrates: A Randomized Clinical Trial. JAMA Netw Open. Published 1 August 2024. doi:10.
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