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Prothrombin complex concentrate in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleeding.

Schick KS, Fertmann JM, Jauch KW, Hoffmann JN - Crit Care (2009)

Bottom Line: This decrease was unrelated to fresh frozen plasma or vitamin K administration.Hemoglobin levels increased significantly from baseline in bleeding patients (P < 0.05) and mean arterial pressure stabilized (P < 0.05).In bleeding patients, the improvement in coagulation after prothrombin complex concentrate administration was judged to be clinically significant.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Surgery, University of Munich - Grosshadern, Marchioninistrasse 15 81377 Munich, Germany. kerstin.schick@med-uni-muenchen.de

ABSTRACT

Introduction: Prothrombin complex concentrates are recommended for rapid reversal of vitamin K anticoagulants. As they normalize levels of vitamin K dependent clotting factors and re-establish hemostasis, they may also be used as adjunctive therapy in patients with major bleeding. The aim of this study was to retrospectively evaluate the efficacy of prothrombin complex concentrates in the surgical setting.

Methods: The case notes of 50 patients requiring urgent oral anticoagulation reversal (n = 12) or with severe perioperative coagulopathic bleeding (n = 38) who received an infusion of prothrombin complex concentrate (Beriplex P/N(R) 500) at the surgical department of the University of Munich Hospital, Germany were retrospectively reviewed. Efficacy of prothrombin complex concentrate application was evaluated using the Quick test, reported as an international normalized ratio, hemodynamic measurements and requirement for blood products. Safety assessments included whole blood hemoglobin levels and specific parameters of organ dysfunction.

Results: Baseline characteristics were comparable, except that mean baseline international normalized ratio and hemoglobin levels were significantly higher (P < 0.01) in anticoagulation reversal than in bleeding patients. In anticoagulation reversal, the international normalized ratio was significantly reduced (from 2.8 +/- 0.2 at baseline to 1.5 +/- 0.1, P < 0.001) after one prothrombin complex concentrate infusion (median dose 1500 IU; lower quartile 1,000, upper quartile 2,000). No major bleeding was observed during surgery after prothrombin complex concentrate administration. Only one patient received platelets and red blood cell transfusion after prothrombin complex concentrate administration. In bleeding patients, infusion of prothrombin complex concentrate (median dose 2,000 IU; lower quartile 2,000, upper quartile 3,000) significantly reduced the INR from 1.7 +/- 0.1 at baseline to 1.4 +/- 0.1 (P < 0.001). This decrease was unrelated to fresh frozen plasma or vitamin K administration. Bleeding stopped after prothrombin complex concentrate administration in 4/11 (36%) patients with surgical bleeding and 26/27 (96%) patients with diffuse bleeding. Hemoglobin levels increased significantly from baseline in bleeding patients (P < 0.05) and mean arterial pressure stabilized (P < 0.05). No thrombotic events or changes in organ function were reported in any patient.

Conclusions: Prothrombin complex concentrate application effectively reduced international normalized ratios in anticoagulation reversal, allowing surgical procedures and interventions without major bleeding. In bleeding patients, the improvement in coagulation after prothrombin complex concentrate administration was judged to be clinically significant.

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Mean ± standard error of the mean hemoglobin concentrations in patients requiring urgent reversal of vitamin K antagonist therapy (reversal) or with severe bleeding (bleeding). White bars: before (baseline); black bars: after infusion of prothrombin complex concentrate. The mean ± SEM units of red blood cells transfused in each patient group are also shown. Light gray bar: patients requiring urgent reversal of vitamin K antagonist therapy; dark gray bar: patients with severe bleeding. * P < 0.05 vs baseline.
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Figure 5: Mean ± standard error of the mean hemoglobin concentrations in patients requiring urgent reversal of vitamin K antagonist therapy (reversal) or with severe bleeding (bleeding). White bars: before (baseline); black bars: after infusion of prothrombin complex concentrate. The mean ± SEM units of red blood cells transfused in each patient group are also shown. Light gray bar: patients requiring urgent reversal of vitamin K antagonist therapy; dark gray bar: patients with severe bleeding. * P < 0.05 vs baseline.

Mentions: Hemoglobin levels increased significantly (P < 0.05) from 8.2 ± 0.3 g/dl at baseline to 10.6 ± 0.2 g/dl after PCC treatment (Figure 5) although a comparable amount of RBC was applied within six hours before and after PCC treatment (Table 3). This finding also indicates cessation of bleeding. The mean number of RBC units administered to bleeding patients was 6.9 ± 2.1, compared with one unit in one anticoagulation reversal patient (Figure 5). After administration of PCC in bleeding patients arterial pressure increased (Figure 6), whereas heart rate was unchanged (Figure 7), indicating hemodynamic stabilization. Serum creatinine and bilirubin concentrations measured three days after administration of PCC were not significantly increased. An increase in CRP was observed, but this was not statistically significant.


Prothrombin complex concentrate in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleeding.

Schick KS, Fertmann JM, Jauch KW, Hoffmann JN - Crit Care (2009)

Mean ± standard error of the mean hemoglobin concentrations in patients requiring urgent reversal of vitamin K antagonist therapy (reversal) or with severe bleeding (bleeding). White bars: before (baseline); black bars: after infusion of prothrombin complex concentrate. The mean ± SEM units of red blood cells transfused in each patient group are also shown. Light gray bar: patients requiring urgent reversal of vitamin K antagonist therapy; dark gray bar: patients with severe bleeding. * P < 0.05 vs baseline.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2811941&req=5

Figure 5: Mean ± standard error of the mean hemoglobin concentrations in patients requiring urgent reversal of vitamin K antagonist therapy (reversal) or with severe bleeding (bleeding). White bars: before (baseline); black bars: after infusion of prothrombin complex concentrate. The mean ± SEM units of red blood cells transfused in each patient group are also shown. Light gray bar: patients requiring urgent reversal of vitamin K antagonist therapy; dark gray bar: patients with severe bleeding. * P < 0.05 vs baseline.
Mentions: Hemoglobin levels increased significantly (P < 0.05) from 8.2 ± 0.3 g/dl at baseline to 10.6 ± 0.2 g/dl after PCC treatment (Figure 5) although a comparable amount of RBC was applied within six hours before and after PCC treatment (Table 3). This finding also indicates cessation of bleeding. The mean number of RBC units administered to bleeding patients was 6.9 ± 2.1, compared with one unit in one anticoagulation reversal patient (Figure 5). After administration of PCC in bleeding patients arterial pressure increased (Figure 6), whereas heart rate was unchanged (Figure 7), indicating hemodynamic stabilization. Serum creatinine and bilirubin concentrations measured three days after administration of PCC were not significantly increased. An increase in CRP was observed, but this was not statistically significant.

Bottom Line: This decrease was unrelated to fresh frozen plasma or vitamin K administration.Hemoglobin levels increased significantly from baseline in bleeding patients (P < 0.05) and mean arterial pressure stabilized (P < 0.05).In bleeding patients, the improvement in coagulation after prothrombin complex concentrate administration was judged to be clinically significant.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Surgery, University of Munich - Grosshadern, Marchioninistrasse 15 81377 Munich, Germany. kerstin.schick@med-uni-muenchen.de

ABSTRACT

Introduction: Prothrombin complex concentrates are recommended for rapid reversal of vitamin K anticoagulants. As they normalize levels of vitamin K dependent clotting factors and re-establish hemostasis, they may also be used as adjunctive therapy in patients with major bleeding. The aim of this study was to retrospectively evaluate the efficacy of prothrombin complex concentrates in the surgical setting.

Methods: The case notes of 50 patients requiring urgent oral anticoagulation reversal (n = 12) or with severe perioperative coagulopathic bleeding (n = 38) who received an infusion of prothrombin complex concentrate (Beriplex P/N(R) 500) at the surgical department of the University of Munich Hospital, Germany were retrospectively reviewed. Efficacy of prothrombin complex concentrate application was evaluated using the Quick test, reported as an international normalized ratio, hemodynamic measurements and requirement for blood products. Safety assessments included whole blood hemoglobin levels and specific parameters of organ dysfunction.

Results: Baseline characteristics were comparable, except that mean baseline international normalized ratio and hemoglobin levels were significantly higher (P < 0.01) in anticoagulation reversal than in bleeding patients. In anticoagulation reversal, the international normalized ratio was significantly reduced (from 2.8 +/- 0.2 at baseline to 1.5 +/- 0.1, P < 0.001) after one prothrombin complex concentrate infusion (median dose 1500 IU; lower quartile 1,000, upper quartile 2,000). No major bleeding was observed during surgery after prothrombin complex concentrate administration. Only one patient received platelets and red blood cell transfusion after prothrombin complex concentrate administration. In bleeding patients, infusion of prothrombin complex concentrate (median dose 2,000 IU; lower quartile 2,000, upper quartile 3,000) significantly reduced the INR from 1.7 +/- 0.1 at baseline to 1.4 +/- 0.1 (P < 0.001). This decrease was unrelated to fresh frozen plasma or vitamin K administration. Bleeding stopped after prothrombin complex concentrate administration in 4/11 (36%) patients with surgical bleeding and 26/27 (96%) patients with diffuse bleeding. Hemoglobin levels increased significantly from baseline in bleeding patients (P < 0.05) and mean arterial pressure stabilized (P < 0.05). No thrombotic events or changes in organ function were reported in any patient.

Conclusions: Prothrombin complex concentrate application effectively reduced international normalized ratios in anticoagulation reversal, allowing surgical procedures and interventions without major bleeding. In bleeding patients, the improvement in coagulation after prothrombin complex concentrate administration was judged to be clinically significant.

Show MeSH
Related in: MedlinePlus