Author(s): Chowdary P., Tang A., Watson D., Besser M., Collins P.W., Creagh M.D., Qureshi H., Rokicka M., Nokes T., Diprose P., Frith S., Gill R.
Abstract: Background: Few studies have investigated the use of prothrombin complex concentrates (PCCs) to control bleeding unrelated to oral anticoagulation. Aims: To examine real-life use of PCC in perioperative and intensive care settings in the UK. Methods: This observational, non-interventional study was conducted across nine centers. Patients with coagulopathy who required surgical/ diagnostic intervention and prophylactic hemostatic treatment (cohort P), or with acute perioperative bleeding requiring hemostatic treatment (cohort T) were included. Patients treated with oral vitamin K antagonists were excluded. The study was approved by an independent ethics committee and informed consent was waived for the data collection. Results: 372 patients received PCC (cohort P: 21; cohort T: 351; PCC alone: 244) and 73 received fresh frozen plasma (FFP) only (cohort P: 19; cohort T: 54). In cohort P, PCC/FFP was administered prophylactically for a wide variety of surgical/medical procedures and investigations. Cardiac surgery was the most common setting in cohort T. The median total dose of PCC in cohort P was 22.5 (IQR: 18.1- 27.3) IU kg <sup>-1</sup>, compared with 11.5 (IQR: 7.1-15.4) IU kg <sup>-1</sup> in cohort T. Clinical effectiveness was judged as very good or satisfactory in 93.0% of patients receiving PCC alone (cohort P: 87.5%; cohort T: 93.4%), There was no significant association between dose and effectiveness among recipients of PCC alone, though bleeding severity differences may have confounded this analysis. Seven thromboembolic events were considered as possibly related to PCC, an incidence comparable to observational studies in cardiac surgery without PCC. One death in a 70-year-old woman with acute promyelocytic leukemia was possibly related to PCC treatment. Conclusion: This study shows the potential for using PCC to treat coagulopathic bleeding in clinical settings beyond oral anticoagulation reversal. The treatment was well tolerated and may have contributed to the effective management of bleeding.
Conference Information: 25th Congress of the International Society on Thrombosis and Haemostasis, ISTH 2015 Toronto, ON Canada. Conference Start: 20150620 Conference End: 20150625
Publication Type: Journal: Conference Abstract