[Safety and efficacy of a prothrombin complex concentrate in patients with coagulopathy and hemorrhage].

Abstract

BACKGROUND:

Prothrombin complex concentrates (PCC) are approved for urgent reversal of vitamin K antagonists (VKA). Recently, PCC have been used in the management of massive bleeding-associated coagulopathy. The present work evaluates safety and efficacy of PCC in a case series of both VKA reversal and massive bleeding.

METHODS:

Retrospective review of cases treated with CCP (January 2010 to February 2013). Safety endpoints were infusion reactions and incidence of thromboembolic events. Efficacy endpoints were: 1) VKA reversal efficacy and 2) Massive bleeding coagulopathy reversal and 24h mortality.

RESULTS:

Thirty-one patients were included (22 male), median age 61 years (range 30-86). No infusion reactions were detected, and only 1 thrombotic episode was observed. VKA reversal was effective in 100% of patients (6/6), all of them with complete reversal of INR value. In massive bleeding, 24-hour survival was 64% (16/25). Invasive hemostatic procedures were required in 28% of patients (7/25). CCP use was correlated with bleeding control in 44% of cases (11/25), and also significantly associated with survival (p=0.01).

CONCLUSION:

CCP are safe and effective for the novel indication of adjuvant treatment in massive bleeding patients, as well as for traditional urgent reversal of VKA.

• Authors: N Martínez-Calle, M Marcos-Jubilar, A Alfonso, M Hernández, F Hidalgo, R Lecumberri, Ja Páramo
• Journal: Anales del sistema sanitario de Navarra (An Sist Sanit Navar) 2014 Sep-Dec Vol. 37 Issue 3 Pg. 363-9 ISSN: 2340-3527 [Electronic] Spain
• Vernacular Title: Seguridad y eficacia de un concentrado de complejo protrombínico en pacientes con coagulopatía y hemorragia.
• PMID: 25567390 (Publication Type: Journal Article)

Chemical References

• Blood Coagulation Factors
• prothrombin complex concentrates

Topics

• Adult
• Aged
• Aged, 80 and over
• Blood Coagulation Disorders (drug therapy)
• Blood Coagulation Factors (therapeutic use)
• Female
• Hemorrhage (drug therapy)
• Humans
• Male
• Middle Aged
• Retrospective Studies
• Treatment Outcome