Four Factor Prothrombin Complex Concentrate Compared to Fresh Frozen Plasma in Patients on Warfarin With Traumatic Intracranial Hemorrhage, a Real-World Analysis
*Shunella Lumas1, *Walter Hsiang1, *Robert D Becher1, Adrian Maung2, Kimberly A Davis1, Kevin M Schuster1
1Yale School of Medicine, New Haven, CT;2Yale University School of Medicine, New Haven, CT
Objective: To assess the real-world impact of recently available 4-factor prothrombin complex concentrate (PCC) on patients with traumatic intracranial hemorrhage (ICH) on warfarin, we compared outcomes among patients who received PCC, fresh frozen plasma (FFP) or no warfarin reversal (NR).
Design: Retrospective analysis using regression models adjusted for admission INR, demographics, comorbidities, concomitant antiplatelet therapy, head AIS and GCS.
Setting: Academic level I trauma center
Patients: Patients admitted 2012-2018, on pre-injury warfarin and with traumatic subarachnoid hemorrhage (SAH), subdural hemorrhage (SDH), epidural hemorrhage (EPH), and/or intraparenchymal hemorrhage (IPH).
Interventions: None
Main Outcome Measures: ICH progression. mortality, need for craniotomy, hospital length of stay (LOS).
Results: Of 150 patients on pre-injury warfarin, 41 patients received FFP, 60 received PCC and 49 NR. Demographics, admission INR and injury severity were similar. Progression of bleed was paradoxically less likely in patients not reversed, and similar between agents (table). Predictors of progression on multivariable analysis included male gender (OR 2.73 95% CI 1.25 - 5.99), SDH (OR 0.37 95% CI 0.14 – 0.99), PCC compared to no reversal (OR 3.91 95% CI 1.43 – 10.64). Warfarin reversal was not associated with craniotomy, mortality or LOS. Over time reversal increased from 68% to 79%, FFP decreased from 68% to 3% and PCC increased from 0% to 76%, p<0.001 for trend.
Conclusions: Male gender and use of PCC were associated with progression of ICH. Choice of reversal agent did not impact need for surgery, LOS or mortality. Some ICH patients may not require warfarin reversal.
| FFP n=41 | 4-factor PCC n=60 | No reversal n=49 | p-value | |
| Age: mean (SD) | 81.2 (9.7) | 81.9 (8.1) | 81.4 (7.3) | 0.889 |
| Male gender n (%) | 18 (43.9) | 35 (58.3) | 24 (49.0) | 0.334 |
| Head AIS: median (IQR) | 1 (1-2) | 2 (1-3) | 2 (1-3) | 0.864 |
| Admission INR: mean (SD) | 2.9 (1.9) | 2.8 (1.3) | 2.0 (1.4) | 0.006 |
| Time to INR ≤ 1.2 (hours) | 21 (15-36) | 10.5 (6-17.5) | n/a | 0.002 |
| Mortality: n (%) | 0 (0.0) | 2 (3.3) | 2 (4.1) | 0.448 |
| Length of Stay: median (IQR) | 6 (3-13) | 4 (3-7) | 4 (2-5) | 0.024 |
| ICH progression: n (%) | 21 (51.2) | 26 (43.3) | 10 (20.4) | 0.006 |
| Need for craniotomy n (%) | 8 (19.5) | 9 (15.0) | 3 (6.1) | 0.157 |
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