Efficacy of the prothrombin complex concentrate prothromplex in patients requiring urgent reversal of vitamin K antagonists or presenting with uncontrolled bleeding: a retrospective, single center study.
The objective of the present study was to investigate the efficacy of a four-factor prothrombin complex concentrate (Prothromplex, PTX) in shortening prolonged international normalized ratio or controlling life-threatening bleeding. The study was a retrospective single-centre study that included 142 patients treated with PTX and allocated in three groups: patients on vitamin K antagonists (VKA) (acenocumarol) and undergoing invasive procedure or presenting with severe bleeding (n = 76), patients treated with VKA presenting with intracranial haemorrhage (n = 22), and patients not on VKA and presenting with uncontrolled bleeding (n = 44). The primary outcome variable was international normalized ratio (INR) return to the norm after PTX infusion. Secondary outcome variables included bleeding control and reduction of transfusion rate. Overall, patients received a median of 1200 IU (≈15 IU/kg) of PTX, and INR decreased from 4 ± 3 to 1.7 ± 1.2 (P < 0.01) in all groups, although it remained at least 1.4 in 38% of patients (29.3% among patients receiving 25 IU/kg vs. 42.6% among those receiving 15 IU/kg; P < 0.05). Patients with initial INR at least 4 benefited the most from treatment. After PTX administration, there was a significant reduction in both transfused blood components units (P < 0.01) and estimated blood loss volume (from 1500 ± 1500 to 200 ± 100 ml; P < 0.01), and only one episode of deep venous thrombosis was observed. Administration of fixed doses of PTX shortened prolonged international normalized ratio and improved life-threatening bleeding in patients with or without VKA therapy. Higher dose attained a more adequate post-infusion INR.
aCritical Care bPharmacy Divisions, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina de Sevilla [IBIS], Seville cGIEMSA, Transfusion Medicine, University of Malaga, Málaga, Spain.
Santiago R
SR
Leal-Noval
Rosa
R
López-Irizo
Javier
J
Bautista-Paloma
Manuel
M
Casado
Victoria
V
Arellano-Orden
María
M
Leal-Romero
Esteban
E
Fernández-Hinojosa
Antonio
A
Puppo-Moreno
Manuel
M
Muñoz
D000074:Acenocoumarol / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000097:blood / Q000139:chemically induced / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors / Q000378:metabolism
D000925:Anticoagulants; D000933:Antifibrinolytic Agents; D001779:Blood Coagulation Factors; D014812:Vitamin K; C025667:prothrombin complex concentrates; D000074:Acenocoumarol