LOS ANGELES – The international normalized ratio fell to 1.2 or less within 3 hours among 18 of 27 (67%) patients who received four-factor prothrombin complex concentrate (octaplex [Octapharma]) for warfarin-related intracranial hemorrhages, but only 2 of 23 (9%) who received fresh frozen plasma, according to a randomized trial from Germany.
Hematoma expansion was reduced by 16.9 mL (P = .026) at 3 hours and 16.4 mL (P = .018) at 24 hours in the prothrombin complex concentrate (PCC) group.
All the patients presented within 12 hours of symptom onset with an INR of at least 2; they received fresh frozen plasma (FFP) or four-factor PCC within an hour of their cerebral CT. There were eight deaths in the FFP group, including five due to hematoma expansion. The five deaths in the PCC group occurred after day 5, and one was thought to be because of hematoma expansion. Patients were 76 years old, on average, and the majority were men; both groups received vitamin K.
The findings make a case for PCC at a time when it’s unclear how best to handle warfarin-related intracranial bleeds, and whether the extra cost of PCC is worth it. Investigator Dr. Thorsten Steiner, a professor of neurology at the University of Heidelberg (Germany), addressed the relevant issues, including PCC safety, in a video interview at the International Stroke Conference sponsored by the American Heart Association. The investigator-initiated trial was funded by Octapharma, and Dr. Steiner reported receiving a research grant from the company.