Desmettre TDehours ESamama CMJhundoo SPujeau FGuillaudin CHecquart CClerson PCrave JCJaussaud R.

ABSTRACT:

INTRODUCTION:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

Suscribe to our newsletter

By clicking on the link below, you will be redirected to Youtube. Third-party cookies may then be installed on your browser. These cookies are not implemented directly by the Soladis Clinical Studies site but by the site to which you connect.
Important: these cookies are subject to their own privacy policies and are in no way the responsibility of Soladis.
You can view Youtube's cookie policy by clicking on the following link: Google – Privacy & terms

  Follow Soladis on Youtube

By clicking on the link below, you will be redirected to LinkedIn. Third-party cookies may then be installed on your browser. These cookies are not implemented directly by the Soladis Clinical Studies site but by the social network site to which you connect.
These cookies are subject to their own privacy policies and are in no way the responsibility of Soladis.
You can view LinkedIn's cookie policy by clicking on the following link :  LinkedIn – Cookie Policy

Follow Soladis on LinkedIn

En cliquant sur le lien ci-dessous, vous allez être redirigé vers Youtube. Des cookies tiers peuvent alors être installés sur votre navigateur. Ces cookies ne sont pas implémentés directement par le site Soladis Clinical Studies mais par le site auquel vous vous connectez.
Important : ces cookies sont soumis à leurs propres politiques de confidentialité et ne relèvent en aucun cas de la responsabilité de Soladis.
Vous pouvez consulter la politique de Youtube en matière de cookies en cliquant sur le lien suivant : Google – Règles de confidentialité et conditions d’utilisation

  Suivre Soladis sur Youtube

En cliquant sur le lien ci-dessous, vous allez être redirigé vers LinkedIn. Des cookies tiers peuvent alors être installés sur votre navigateur. Ces cookies ne sont pas implémentés directement par le site Soladis Clinical Studies mais par le site de réseau social auquel vous vous connectez.
Ces cookies sont soumis à leurs propres politiques de confidentialité et ne relèvent en aucun cas de la responsabilité de Soladis.
Vous pouvez consulter la politique de LinkedIn en matière de cookies en cliquant sur le lien suivant : LinkedIn – Politique relative aux cookies

  Suivre Soladis sur LinkedIn