title: Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: experience in a large tertiary hospital.
abstract: BACKGROUND
  Major blood loss can often be life-threatening and is most commonly encountered in the settings of surgery and trauma. Patients receiving anticoagulant therapy are also at increased risk of bleeding. We investigated the use of a prothrombin complex concentrate (PCC; Beriplex P/N, CSL Behring, Marburg, Germany) to treat severe bleeding in a variety of settings: cardiac surgery, warfarin therapy and other surgery.
  
  
  METHODS
  Thirty consecutive patients who had received PCC were identified from blood transfusion records. For cardiac surgery and warfarin reversal, PCC was administered in accordance with hospital protocols. PCC was administered to cardiac and other surgical patients responding poorly to recognized blood products, whereas it was administered first-line to patients with life-threatening bleeds and requiring warfarin reversal, in accordance with British Committee for Standards in Haematology guidelines. We conducted a retrospective analysis of patient records in order to ascertain PCC dose, use of other blood products and response to PCC (clotting screen results before and after PCC administration, haemostasis achievement, and survival).
  
  
  RESULTS
  Six patients (20%) were excluded because of inadequate documentation (n = 5) or acquired haemophilia (n = 1). Therefore, 24 patients were included in the analysis: coronary artery bypass graft (n = 5), mitral/aortic valve replacement (n = 2), other surgery (n = 9) and warfarin reversal (n = 8). Most patients (83.3%) received no more than 1500 IU of Beriplex P/N 500. Considerable reduction in administration of other blood products was seen during the 24 hours after PCC administration. Partial or complete haemostasis was achieved in 14 out of 18 cases (77.8%). In total, 12 out of 24 patients (50%) died during the study; two-thirds of the deaths were considered unrelated to bleeding. No thrombotic complications or adverse drug reactions were observed.
  
  
  CONCLUSIONS
  This study emphasizes the value of PCC in reversing the effects of oral anticoagulant therapy in bleeding patients. It also demonstrates the potential value of PCC in controlling bleeding in patients undergoing cardiac and other surgical procedures. The use of PCC in bleeding patients without hereditary or anticoagulation-related coagulopathy is novel, and further investigation is warranted. In the future, it may be possible to use PCC as a substitute for fresh frozen plasma in this setting; adequate documentation is crucial for all blood products.
authors.affiliation: Department of Haematology, Derriford Hospital, Brest Road, Plymouth, Devon PL6 8DH, UK.
authors.forename: David
authors.initials: D
authors.lastname: Bruce
authors.forename: Tim J C
authors.initials: TJ
authors.lastname: Nokes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001779:Blood Coagulation Factors / Q000627:therapeutic use; D013504:Cardiovascular Surgical Procedures / Q000009:adverse effects; D004338:Drug Combinations; D005164:Factor IX / Q000627:therapeutic use*; D005167:Factor VII / Q000627:therapeutic use*; D005170:Factor X / Q000627:therapeutic use*; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D006786:Hospitals, Urban; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D011516:Prothrombin / Q000627:therapeutic use*; D012189:Retrospective Studies
chemical_list: D001779:Blood Coagulation Factors; D004338:Drug Combinations; C525441:factor IX, factor VII, factor X, prothrombin drug combination; C025667:prothrombin complex concentrates; D005167:Factor VII; D011516:Prothrombin; D005164:Factor IX; D005170:Factor X