Reversal of Vitamin K Antagonist (VKA) effect in patients with severe bleeding: a French multicenter observational study (Optiplex) assessing the use of Prothrombin Complex Concentrate (PCC) in current clinical practice
1 Urgences/SAMU 25, CHU Besançon, Université de Franche Comté, 1 Bd Fleming, Besançon, 25000, France
2 Pôle de Médecine d'Urgence, CHU Purpan, Place du Dr Baylac, Toulouse, 31059, France
3 Anesthésie-Réanimation, CHU Hôtel-Dieu, Université Paris Descartes, 1 place du Parvis Notre Dame, Paris, 75181, France
4 Urgences, CH Saint Jean, 20 avenue du Languedoc, Perpignan, 66000, France
5 Urgences, CH Pau, 4 Bd Hauterive, Pau, 64046, France
6 Pharmacie, CH Saint Esprit, lieu dit saint esprit, Agen, 47000, France
7 Pharmacie, CHU Côte de Nacre, avenue de la Côte de Nacre, Caen, 14000, France
8 Orgamétrie biostatistiques, 84 Bd Général Leclerc, Roubaix, 59100, France
9 Département médical, Octapharma-France SAS, 62 avenue André Morizet, Boulogne Billancourt, 92100, France
10 Médecine Interne, Hôpital Robert Debré, Avenue du Général Koenig, Reims, 51092, France
Critical Care 2012, 16:R185 doi:10.1186/cc11669Published: 4 October 2012
Prothrombin Complex Concentrate (PCC) is a key treatment in the management of bleeding related to Vitamin K antagonists (VKA). This study aimed to evaluate prospectively PCC use in patients with VKA-related bleeding in view of the French guidelines published in 2008.
All consecutive patients with VKA-related bleeding treated with a 4-factor PCC (Octaplex®) were selected in 33 French hospitals. Collected data included demographics, site and severity of bleeding, modalities of PCC administration, International Normalized Ratio (INR) values before and after PCC administration, outcomes and survival rate 15 days after infusion.
Of 825 patients who received PCC between August 2008 and December 2010, 646 had severe bleeding. The main haemorrhage sites were intracranial (43.7%) and abdominal (24.3%). Mean INR before PCC was 4.4 ± 1.9; INR was unavailable in 12.5% of patients. The proportions of patients who received a PCC dose according to guidelines were 15.8% in patients with initial INR 2-2.5, 41.5% in patients with INR 2.5-3, 40.8% in patients with INR 3-3.5, 26.9% in patients with INR > 3.5, and 63.5% of patients with unknown INR. Vitamin K was administered in 84.7% of patients. The infused dose of PCC did not vary with initial INR; the mean dose was 25.3 ± 9.8 IU/Kg. Rates of controlled bleeding and target INR achievement were similar, regardless of whether or not patients were receiving PCC doses as per the guidelines. No differences in INR after PCC treatment were observed, regardless of whether or not vitamin K was administered. INR was first monitored after a mean time frame of 4.5 ± 5.6 hours post PCC. The overall survival rate at 15 days after PCC infusion was 75.4% (65.1% in patients with intracranial haemorrhage). A better prognosis was observed in patients reaching the target INR.
Severe bleeding related to VKA needs to be better managed, particularly regarding the PCC infused dose, INR monitoring and administration of vitamin K. A dose of 25 IU/kg PCC appears to be efficacious in achieving a target INR of 1.5. Further studies are required to assess whether adjusting PCC dose and/or better management of INR would improve outcomes.