title: PROTHROMBINEX(®)-VF (PTX-VF) usage for reversal of coagulopathy: prospective evaluation of thrombogenic risk.
abstract: BACKGROUND
  Prothrombin complex concentrates (PCCs) are used for the urgent reversal of oral vitamin K antagonists in patients with life-threatening bleeding or prior to urgent procedures/surgery. PCCs offer rapid and complete reversal without the disadvantages of volume overload and adverse reactions seen with fresh frozen plasma (FFP). There is concern about the risk of thrombosis associated with the use PCCs; data on this is limited at present.
  
  
  OBJECTIVE
  To determine the incidence of objectively confirmed arterial or venous thromboembolism within 30 days following the administration of PROTHROMBINEX®-VF (PTX-VF) to acutely reverse a prolonged INR.
  
  
  METHODS
  A prospective observational study was conducted at two teaching hospitals in Auckland, NZ. All patients who received PTX-VF for the acute reversal of prolonged INR were eligible. Baseline patient demographics and reasons for PTX-VF administration were recorded. Patients were reviewed at days 7 and 30, to confirm/exclude thromboembolism or adverse events.
  
  
  RESULTS
  173 patients were enrolled from August 2008 to March 2009. The most frequent indication for reversal was acute bleeding. At 30 days 4.6% (8/173) patients had a definite/probable thrombotic event, and 16.7% had died either due to the presenting bleed (intracranial haemorrhage) or a complication of their presenting complaint (e.g. sepsis, renal failure).
  
  
  CONCLUSIONS
  Acute reversal of anticoagulant therapy with PTX-VF is associated with a significant rate of thromboembolism (4.6%) within 30 days. These events can be explained by ongoing cessation of anticoagulant therapy in patients with ongoing risk factors for arterial or venous thrombosis, rather than directly attributable to PTX-VF therapy.
authors.affiliation: Waitemata District Health Board, Auckland, NZ.
authors.forename: Louise
authors.initials: L
authors.lastname: Bobbitt
authors.forename: Eileen
authors.initials: E
authors.lastname: Merriman
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Raynes
authors.forename: Ross
authors.initials: R
authors.lastname: Henderson
authors.forename: Hilary
authors.initials: H
authors.lastname: Blacklock
authors.forename: Sanjeev
authors.initials: S
authors.lastname: Chunilal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001779:Blood Coagulation Factors / Q000008:administration & dosage / Q000378:metabolism*; D005260:Female; D006801:Humans; D019934:International Normalized Ratio / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D013927:Thrombosis / Q000139:chemically induced*; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors / Q000627:therapeutic use; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; D014812:Vitamin K; C025667:prothrombin complex concentrates; D014859:Warfarin