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Background: 3 Factor Prothrombin Complex Concentrates have been used off label with plasma products for effective and timely reversal of INR in patients on Warfarin presenting with severe bleeding. The exact dosage required for this purpose has yet to be determined. Methods: We conducted a retrospective review of all patients taking Warfarin who presented to our institution between January 1, 2013 to June 30, 2014 who received 3 Factor Prothrombin Complex Concentrate (PCC) Bebulin® for INR reversal for significant/lifethreatening bleeding. The dose of Bebulin was determined by clinical judgment by the blood bank and the treating physician in accordance with the patient’s weight, bleeding location and the presenting INR. Results: A total of 116 patients were treated. Mean age was 72 years. Forty-two (36.21%) of patients were female. Most common bleeding site was intracranial (n=61), followed by systemic hemorrhage (n=24), GI bleeding (n=16), trauma (n=10) and other bleed (n=5). Some patients were also on other anticoagulants besides Warfarin – 28 patients (24%) were on Aspirin and 9 (7.8%) on Plavix. The mean INR prior to Bebulin treatment was 3.62 which dropped to 2.05 at an average of 2.2 hours post-treatment. Mean level at 12 hour post-Bebulin dropped to 1.57. The average patient received 2 units of plasma and 1 unit of packed red cell transfusions. The average Bebulin dose administered was 959 IU (SD +/-465 IU) with average patient weight of 82.9 kg (SD +/- 27kg). Based on this the average Bebulin dose administered was 11.57 IU/kg. Eighty-eight patients (76%) were able to be discharged home or to a skilled nursing facility. Thirty-six patients (31.1%) required more than one dose of Bebulin®. Mean INR at presentation in this group of patients were not similar to the remainder of the group. Mean INR at average of 2.5 hours post-Bebulin in this group was 2.18 which dropped further to an average of 1.75 at 9 hours. The total average Bebulin dose incrementally administered was similar in both groups. Conclusion: Low dose Bebulin at doses of approximately 12 IU/kg with 2 Units of plasma was effective in timely reversal of INR in majority of patients who presented with Warfarin induced bleeding. Disclosures Off Label Use: Bebulin (3 Factor PCC) is approved for use in Hemophilia patients; we discuss using low dose for INR reversal in Warfarin associated bleeding.

mortality, it is important to quantify the impact of therapy on developing this adverse event. The number needed to treat (NNT) is a useful measure that can illustrate the effectiveness of an intervention for physician decisionmaking. The objective of this analysis is to quantify the NNT to avoid one event of volume overload in patients receiving 4F-PCC versus plasma for reversal of vitamin K antagonists. Methods: The NNT was determined by calculating the inverse of the absolute risk reduction of volume overload due to 4F-PCC versus plasma using data collected from two open-label, multicenter, phase IIIb clinical trials. In both trials patients were randomly assigned (1:1) to receive either 4F-PCC or plasma. In total, 388 patients (4F-PCC, n¼191; plasma, n¼197) were enrolled. Volume overload occurred in 9 (5%) patients treated with 4F-PCC compared to 25 (13%) patients treated with plasma. In the clinical trials, volume overload events included fluid overload, pulmonary edema, congestive cardiac failure, chronic cardiac failure, and cardiac failure. In addition, the benefit per 100 treated patients was calculated by finding the difference in volume overload events that occurred between one scenario in which 100 patients were treated with 4F-PCC and another scenario in which 100 patients were treated with plasma. Results: The NNT with 4F-PCC, instead of plasma, to avoid one episode of volume overload ranges between 0 and 33.6 among various patient populations (Table 1). These results quantify the extent to which 4F-PCC reduces the likelihood of volume overload. Overall, the average pooled NNT is approximately 12.5. Conclusion: Our pooled analysis suggests that approximately 13 patients need to receive 4F-PCC rather than plasma to avoid one episode of clinically relevant volume overload. For perspective, the NNT with warfarin instead of aspirin to prevent one ischemic stroke is 60 patients. These data may help providers weigh the risks versus benefits of varied treatment options for patients requiring emergency anticoagulation reversal.