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SAFETY AND EFFICACY OF A PROTHROMBIN COMPLEX CONCENTRATE IN VKA REVERSAL AND OFF-LABEL INDICATIONS
Author(s):
María Marcos Jubilar
,
María Marcos Jubilar
Affiliations:
Hematology and Hemotherapy,Clínica Universidad de Navarra,Pamplona,Spain
Jose Antonio Garcia Erce
,
Jose Antonio Garcia Erce
Affiliations:
Hematology and Hemotherapy,Complejo Hospitalario de Navarra,Pamplona,Spain
Nicolas Martinez Calle
,
Nicolas Martinez Calle
Affiliations:
Hematology and Hemotherapy,Clínica Universidad de Navarra,Pamplona,Spain
Jose Antonio Paramo
,
Jose Antonio Paramo
Affiliations:
Hematology and Hemotherapy,Clínica Universidad de Navarra,Pamplona,Spain
Rocio Figueroa
,
Rocio Figueroa
Affiliations:
Hematology and Hemotherapy,Clínica Universidad de Navarra,Pamplona,Spain
Sara Villar
,
Sara Villar
Affiliations:
Hematology and Hemotherapy,Clínica Universidad de Navarra,Pamplona,Spain
Manuel Quintana
Manuel Quintana
Affiliations:
Intensive Medicine,Hospital Universitario La Paz,Madrid,Spain
(Abstract release date: 05/18/17) EHA Library. MARCOS JUBILAR M. 05/18/17; 182943; PB2230
MARIA MARCOS JUBILAR
MARIA MARCOS JUBILAR
Contributions
PDF Abstract
Abstract

Abstract: PB2230

Type: Publication Only

Background

Prothrombin complex concentrates (PCC) are highly purified mixtures of plasma coagulation factors that contains vitamin K dependent and anticoagulation factors, they are approved for urgent reversal of vitamin K antagonists (VKA). Massive bleeding-associated coagulopathy guidelines include PCC in their management, although as an off-label indication.

Aims

The aim of the present work is to evaluate safety and efficacy of PCC in a case series of VKA reversal and refractory coagulopathy associated with major bleeding.

Methods
Retrospective review of cases treated with a four-factor PCC between January 2010 to January 2016 in two tertiary Universitary Hospitals. As safety endpoints we evaluated infusion reactions and incidence of thromboembolic events by self reported registry. The efficacy endpoints were studied in two separate cohorts: 1) INR correction for VKA reversal and 2) coagulopathy correction and early mortality (24 hours) in major bleeding coagulopathy.

Results

328 patients were included (47.25% male), median age 78 years (range 19-102). PCC was used in the following cases: 1) 66.67% in VKA reversal indication (181 patients due to hemorrhage and 33 prior to emergent surgery), mean dose of PCC 1333.51 IU; 2) 30.54% in refractory coagulopathy in major bleeding (30 patients due to massive bleeding protocol activation, 43 patients in hepathopathy coagulopathy and 25 patients in bleeding not related with any of previous reasons) a mean dose of PCC 1681.63 IU was used.
Safety endpoint: Two infusion reactions were reported potentially related to PCC use, they were not specified neither as anafilaxia nor as pulmonary edema, and 8 thrombotic episodes were observed (2.4%): 5 pulmonary embolism, 2 deep venous thrombosis and 1 portal thrombosis, 75% of the events appear in the group of VKA reversal.
Efficacy endpoint: VKA reversal in bleeding patients was effective in 97% of them, 76.5% with complete reversal of INR value (INR<1,5), 34,25% of patients required red blood cell (RBC) transfusion, with a mean of 1.32 RBC. Prior to invasive procedure VKA reversal was effective in 83% of patients, all procedures taking place with no bleeding complication, 36,3% of patients needed RBC with a mean of 1.12 units.
24 hours mortality in refractory coagulopathy associated to major bleeding was 31,6%, having a worse outcome (40% rate of death) those who suffer a massive bleeding coagulopathy, all death related with absence of bleeding control. A global INR correction happen in 76.7% of patients, complete correction in 40.7%. 63,26% received previous to PCC fresh frozen plasma.
Invasive hemostatic procedures were required in 20% of the whole series.

Conclusion
A four-factor prothrombin complex was safe and effective as adjuvant treatment in refractory coagulopathy due to major bleeding as well as for the emergent reversal of VKA.

Session topic: 30. Transfusion medicine

Keyword(s): Hemorrhage

Abstract: PB2230

Type: Publication Only

Background

Prothrombin complex concentrates (PCC) are highly purified mixtures of plasma coagulation factors that contains vitamin K dependent and anticoagulation factors, they are approved for urgent reversal of vitamin K antagonists (VKA). Massive bleeding-associated coagulopathy guidelines include PCC in their management, although as an off-label indication.

Aims

The aim of the present work is to evaluate safety and efficacy of PCC in a case series of VKA reversal and refractory coagulopathy associated with major bleeding.

Methods
Retrospective review of cases treated with a four-factor PCC between January 2010 to January 2016 in two tertiary Universitary Hospitals. As safety endpoints we evaluated infusion reactions and incidence of thromboembolic events by self reported registry. The efficacy endpoints were studied in two separate cohorts: 1) INR correction for VKA reversal and 2) coagulopathy correction and early mortality (24 hours) in major bleeding coagulopathy.

Results

328 patients were included (47.25% male), median age 78 years (range 19-102). PCC was used in the following cases: 1) 66.67% in VKA reversal indication (181 patients due to hemorrhage and 33 prior to emergent surgery), mean dose of PCC 1333.51 IU; 2) 30.54% in refractory coagulopathy in major bleeding (30 patients due to massive bleeding protocol activation, 43 patients in hepathopathy coagulopathy and 25 patients in bleeding not related with any of previous reasons) a mean dose of PCC 1681.63 IU was used.
Safety endpoint: Two infusion reactions were reported potentially related to PCC use, they were not specified neither as anafilaxia nor as pulmonary edema, and 8 thrombotic episodes were observed (2.4%): 5 pulmonary embolism, 2 deep venous thrombosis and 1 portal thrombosis, 75% of the events appear in the group of VKA reversal.
Efficacy endpoint: VKA reversal in bleeding patients was effective in 97% of them, 76.5% with complete reversal of INR value (INR<1,5), 34,25% of patients required red blood cell (RBC) transfusion, with a mean of 1.32 RBC. Prior to invasive procedure VKA reversal was effective in 83% of patients, all procedures taking place with no bleeding complication, 36,3% of patients needed RBC with a mean of 1.12 units.
24 hours mortality in refractory coagulopathy associated to major bleeding was 31,6%, having a worse outcome (40% rate of death) those who suffer a massive bleeding coagulopathy, all death related with absence of bleeding control. A global INR correction happen in 76.7% of patients, complete correction in 40.7%. 63,26% received previous to PCC fresh frozen plasma.
Invasive hemostatic procedures were required in 20% of the whole series.

Conclusion
A four-factor prothrombin complex was safe and effective as adjuvant treatment in refractory coagulopathy due to major bleeding as well as for the emergent reversal of VKA.

Session topic: 30. Transfusion medicine

Keyword(s): Hemorrhage

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