Key result
Low-dose 4-factor prothrombin complex concentrate (35 U/kg) achieved hemostasis in 83.8% of patients presenting with a major bleed while on a direct factor Xa inhibitor.
Why the study?
Does low-dose 4-factor PCC 35 U/kg improve hemostasis in bleeding patients on direct factor Xa inhibitors?
Observational (n=33)
No
Does low-dose 4-factor PCC 35 U/kg improve hemostasis in bleeding patients on direct factor Xa inhibitors?
Low-dose 4-factor PCC (35 U/kg) effectively achieves hemostasis in the majority of bleeding patients on direct factor Xa inhibitors without causing thromboembolic events.
May support low-dose 4-factor PCC for FXa inhibitor bleeds; hypothesis-generating and requires randomized confirmation before practice change.
OBJECTIVE: This study investigated the percentage of patients who achieved hemostasis with 4-factor prothrombin complex concentrate (4-factor PCC) 35 U/kg. The primary end point was to determine the effect of 4-factor PCC 35 U/kg on bleeding progression, assessed using computed tomography. METHODS: This was a retrospective, observational, single-center study conducted in patients with a major bleed admitted to a level 1 trauma center from May 1, 2013, to June 15, 2015, who received 4-factor PCC 35 U/kg for reversal of a direct factor Xa inhibitor taken prior to admission. RESULTS: Thirty-three patients were included in the study, with 31 patients in the final analysis. The mean (standard deviation) age was 73 (14.8) years; 54.5% of patients were female. Of the 33 patients, 13 presented with a traumatic brain injury, 9 with an aneurysmal subarachnoid hemorrhage, 8 with an intracerebral hemorrhage, 1 with a gastrointestinal bleed, 1 with a hematoma with active extravasation, and 1 with an intra-abdominal bleed. The most frequently used direct factor Xa inhibitor was rivaroxaban (81.8%). Overall, 83.8% of patients achieved hemostasis with 4-factor PCC 35 U/kg. Progression of hemorrhage was observed in 4 patients on repeat computed tomography scan and 1 patient had continued surgical bleeding. No thromboembolic events were reported. CONCLUSIONS: Low-dose, 4-factor PCC 35 U/kg appeared to produce hemostasis in a majority of the patients. This may be an effective dosing regimen for anticoagulant reversal of factor Xa inhibitors in clinically bleeding patients.
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Allison et al. (2018) conducted an observational in Major bleed on direct factor Xa inhibitor (n=33). 4-factor prothrombin complex concentrate (4-factor PCC) was evaluated on Hemostasis and bleeding progression. Low-dose 4-factor prothrombin complex concentrate (35 U/kg) achieved hemostasis in 83.8% of patients presenting with a major bleed while on a direct factor Xa inhibitor.
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