Abstract
IntroductionProthrombin 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.MethodsAll 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.ResultsOf 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.ConclusionsSevere 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.
Highlights
Prothrombin Complex Concentrate (PCC) is a key treatment in the management of bleeding related to Vitamin K antagonists (VKA)
Severe bleeding related to VKA needs to be better managed, regarding the PCC infused dose, international normalized ratio (INR) monitoring and administration of vitamin K
No differences were noted between the value of INR after PCC treatment in the group that received vitamin K compared with the group that did not receive vitamin K, regardless of the time of INR measurement: H+30 minutes, H+60 minutes, H+6 hours, and H+24 hours
Summary
Prothrombin Complex Concentrate (PCC) is a key treatment in the management of bleeding related to Vitamin K antagonists (VKA). The rates of intracranial hemorrhages range from 0.25% to 1.1% per year to about 2% when the international normalized ratio (INR) exceeds 2 and rise dramatically thereafter [10,11,12,13,14]. Intracranial hemorrhages related to VKA have a high mortality rate, approaching 50% at 1 month [7]. The prognosis of patients with VKA-related intracranial hemorrhage is generally poor compared with that of patients with spontaneous intracranial hemorrhage. In these patients, the hemorrhage is larger at baseline and hematoma expansion may persist after admission [15,16,17]. Coagulation reversal should be initiated as soon as symptom onset occurs to prevent hematoma expansion [16,19,20,21]
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