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Efficacy and safety of a 4-factor prothrombin complex concentrate for management of direct Xa inhibitor-induced major bleeding
ISTH Academy. Dobesh P. 07/09/19; 264679; PB1489 Topic: Management of Bleeding & Trauma
Dr. Paul P Dobesh
Dr. Paul P Dobesh
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PB1489

Efficacy and Safety of a 4-factor Prothrombin Complex Concentrate for Management of Direct Xa Inhibitor-induced Major Bleeding

P. Dobesh, M. Borsh, K. Marth, K. Sorensen, B. Trevarrow
University of Nebraska Medical Center, Pharmacy Practice and Science, Omaha, United States

Main Topic: Hemophilia and Bleeding (including Transfusion)
Category: Management of Bleeding & Trauma

Background: While a specific antidote for direct Xa inhibitors is available, many institutions still use 4-factor prothrombin complex concentrate (4PCC) based on lower cost. Although 4PCC has demonstrated the ability to reverse coagulation parameters in healthy subjects, efficacy and safety data are lacking in patients with current significant bleeding events.
Aims: Assess the efficacy and safety of 4PCC in management of direct Xa inhibitor-induced bleeding in real world practice.
Methods: This retrospective study included all patients who received 4PCC at our hospital for a significant bleeding event while on a direct Xa-inhibitor from 11/2014 to 6/2018. Patients receiving other anticoagulants were excluded from the analysis. Patient demographics, medication use, laboratory values, and outcomes were collected from patient charts. All descriptive data are presented as mean ± standard deviation.
Results: We identified 52 patients who received 4PCC for management of direct Xa inhibitor-induced significant bleeding, 67% of which were cranial and 45% of which were traumatic. Information on patient demographics, direct Xa inhibitor type and indication are found in Table 1.Platelet inhibitors were used in 44% of patients. The 4PCC dose was 3430±1314 units at 40.4±11.8 units/kg. 4PCC stopped bleeding in 65% patients, while 19% required surgery to stop bleeding. 4PCC stopped bleeding within 61.8±104.8 hours, which was similar between cranial and non-cranial bleeding. Ten patients also received PRBC and 17 received FFP and/or platelets. The mortality rate was 25% during hospitalization, and four thrombotic events occurred within the subsequent 30 days.
Conclusions: 4PCC was effective in only two-thirds of patients and documented bleeding termination took several days. While thrombotic events were rare, the efficacy of 4PCC was not ideal. 4PCC may not be the optimal agent for management of direct Xa inhibitor-induced significant bleeding.


Female sex n=32, 62%
Weight (kg) 80.3 ± 20.3
Body mass index 29.9 ± 7.6
HASBLED Score 2.0±1.0
Total length of stay (days) 10.6 ± 9.1
ICU length of stay (days) 6.5 ± 11.3
Therapy for atrial fibrillation n=33, 63%
Therapy for venous thromboembolism n=19, 37%
Use of rivaroxaban n=18, 35%
Use of apixaban n=34, 65%
[Patient Information]

PB1489

Efficacy and Safety of a 4-factor Prothrombin Complex Concentrate for Management of Direct Xa Inhibitor-induced Major Bleeding

P. Dobesh, M. Borsh, K. Marth, K. Sorensen, B. Trevarrow
University of Nebraska Medical Center, Pharmacy Practice and Science, Omaha, United States

Main Topic: Hemophilia and Bleeding (including Transfusion)
Category: Management of Bleeding & Trauma

Background: While a specific antidote for direct Xa inhibitors is available, many institutions still use 4-factor prothrombin complex concentrate (4PCC) based on lower cost. Although 4PCC has demonstrated the ability to reverse coagulation parameters in healthy subjects, efficacy and safety data are lacking in patients with current significant bleeding events.
Aims: Assess the efficacy and safety of 4PCC in management of direct Xa inhibitor-induced bleeding in real world practice.
Methods: This retrospective study included all patients who received 4PCC at our hospital for a significant bleeding event while on a direct Xa-inhibitor from 11/2014 to 6/2018. Patients receiving other anticoagulants were excluded from the analysis. Patient demographics, medication use, laboratory values, and outcomes were collected from patient charts. All descriptive data are presented as mean ± standard deviation.
Results: We identified 52 patients who received 4PCC for management of direct Xa inhibitor-induced significant bleeding, 67% of which were cranial and 45% of which were traumatic. Information on patient demographics, direct Xa inhibitor type and indication are found in Table 1.Platelet inhibitors were used in 44% of patients. The 4PCC dose was 3430±1314 units at 40.4±11.8 units/kg. 4PCC stopped bleeding in 65% patients, while 19% required surgery to stop bleeding. 4PCC stopped bleeding within 61.8±104.8 hours, which was similar between cranial and non-cranial bleeding. Ten patients also received PRBC and 17 received FFP and/or platelets. The mortality rate was 25% during hospitalization, and four thrombotic events occurred within the subsequent 30 days.
Conclusions: 4PCC was effective in only two-thirds of patients and documented bleeding termination took several days. While thrombotic events were rare, the efficacy of 4PCC was not ideal. 4PCC may not be the optimal agent for management of direct Xa inhibitor-induced significant bleeding.


Female sex n=32, 62%
Weight (kg) 80.3 ± 20.3
Body mass index 29.9 ± 7.6
HASBLED Score 2.0±1.0
Total length of stay (days) 10.6 ± 9.1
ICU length of stay (days) 6.5 ± 11.3
Therapy for atrial fibrillation n=33, 63%
Therapy for venous thromboembolism n=19, 37%
Use of rivaroxaban n=18, 35%
Use of apixaban n=34, 65%
[Patient Information]

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