Use of Human Prothrombin Complex Concentrate in Patients with Acquired Deficiency and Active or in High-Risk Severe Bleeding

REVIEW ARTICLE

Use of Human Prothrombin Complex Concentrate in Patients with Acquired Deficiency and Active or in High-Risk Severe Bleeding

Mendarte L^1, Munne M^1, Rodríguez S^2, Mendarte U³ and Montoro JB¹

Affiliations: ¹Pharmacy Service; ²Haematology Service and ³Digestive Service, Donostia Ospitalea, Donostia, Hospital Universitario Vall d'Hebron, Barcelona, Spain


ABSTRACT

BACKGROUND
Deficiency in prothrombin complex factors is a cause of massive hemorrhage, whose management in emergency situations is subject of debate. Plasma-derived prothrombin complex concentrates (PCC) are indicated for reversing the hemorrhagic diathesis found in acquired deficiencies, together with platelets, fresh frozen plasma (FFP), and cryoprecipitate.

OBJECTIVES
To ascertain how PCC are used in patients with life-threatening hemorrhagic disorders (surgery, trauma, digestive hemorrhage), especially in patients with underlying disease states that limit prothrombin complex factor synthesis (hepatic dysfunction, treatment with oral anticoagulants (OAT)), efficiency is evaluated in terms of concrete clinical situation use and stated as international normalized ratio (INR) change and survival at the end of the episode.

METHODS
In a third-level general hospital, patients with a documented life-threatening hemorrhage who received a PCC prescription were included in the protocol, during a follow-up period of 6 months. Demographic data, treatment indication, INR before and after treatment, hemoglobin (Hgb), hematocrit (Hct), admission diagnosis, PCC dose, current OAT, and treatment with vitamin K, and FFP or other hemoderivative administration were collected.

RESULTS
A total of 124 patients were initially treated with PCC, 102 of whom were finally included. Patients' mean age was 63.73 years (SD 17.82); 67 (66%) were men. Only 39% of patients were treated with OAT prior to the emergency bleeding. Mean PCC dose given was 2720 IU (1551) expressed as factor IX; mean INR before treatment was 2.92 (2.54), and INR after PCC administration was 1.47 (0.44); mean INR variation was – 1.54 (2.89) (P<0.005). Global survival at the end of the episode was 61.2%. No thrombotic events were observed directly.

CONCLUSIONS
PCC seem to be a good alternative to FFP in patients with life-threatening hemorrhagic disorders, especially in OAT patients who need OAT reversion, for severe bleeding or surgery. PCC quickly and significantly reduce INR and bleeding in OAT and non-OAT patients. Moreover, PCC are safer than other blood products and reduce the need for other hemoderivatives.

Keywords: prothrombin complex concentrate, emergency bleeding, oral anticoagulant reversion

Correspondence: Mendarte L, Pharmacy Service, Hospital Universitario Vall d'Hebron, Pø Vall d'Hebron 119-129, Barcelona 08035, Spain. Tel: (34)-932746811; Fax: (34)-932746046; e-mail: iyibcn@vhebron.net