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

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).