Comparison of 4F-PCC in obese and nonobese patients with life-threatening bleeding or requiring emergent surgery

Abstract

Background: Four-factor prothrombin complex concentrate (4F-PCC) dosing is based on INR and actual body weight (ABW), with maximum doses not to exceed the dose used in patients weighing >100 kg (Kcentra PI). There are limited data comparing the efficacy of 4F-PCC between patients with low body weight ≤100 kg (LoWT) and high body weight >100 kg (HiWT). Methods: We conducted a retrospective cohort study of patients on warfarin who received 4F-PCC for life-threatening major bleeding or requiring emergent surgery between January 2015 to June 2018 at three academic medical centers. These data were combined with a dataset from 2 randomized Phase 3b clinical trials. Results: We included 388 patients who received 4F-PCC, 318 (82%) were LoWT, and 70 (18%) were HiWT. Indication for 4F-PCC for life-threatening bleeding and emergent surgery was 266 (69%) and 122 (31%) patients, respectively. The most common bleeding type was intracranial hemorrhage (41%), followed by gastrointestinal (36%). The median dose was 2283 units (25 units/kg), and 2.1% of patients required a repeat dose. Conclusion: In those >100 kg, we found no difference in achieving international normalized ratio (INR) ≤1.3, hemostasis in intracranial hemorrhage, or thrombosis. In-hospital mortality occurred 15% in LoWt versus 6% in HiWT (CI 1.8%–17%, p = 0.034). Achievement of INR ≤ 1.5 was significantly lower in the LoWT group compared to the HiWT group (80% versus 91%, CI −20% to −2.5%, p = 0.03).