Prothrombin complex concentrate use in surgical patients: a retrospective analysis of efficacy and safety for coumarin reversal and bleeding management

Introduction

Anticoagulation, coagulation disorders and haemorrhage are causing considerable morbidity and mortality in surgical patients. Reversal of vitamin K anticoagulants and treatment of perioperative coagulopathy can be achieved by prothrombin complex concentrates (PCC). However, the effects on coagulation parameters, and any side effects on organ function, have yet to be determined.

Methods

Patients of the surgical department were analysed during 1 year retrospectively by reviewing patient charts and documentation in a case-note review. Patients with vitamin K antagonist reversal (reversal group: n = 12) were compared with patients receiving PCC for management of severe bleeding (bleeding group, n = 38). Coagulation was assessed using thromboplastin times (INR/Quick's value). Serum bilirubin and creatinine concentrations at day 3 after PCC application served as safety variables.

Results

Both patient groups were comparable in terms of age (reversal: 67.3 ± 4.1 years vs bleeding: 66.1 ± 1.8 years) and body temperature (37.2 ± 0.2°C vs 36.8 ± 0.3°C). Thromboplastin times (INR) before PCC treatment were significantly higher in the reversal group (reversal: 2.4 ± 0.2 vs bleeding: 1.5 ± 0.2; P < 0.001), whereas anaemia occurred significantly more frequently in bleeding patients (haemoglobin: reversal 11.8 ± 0.6 g/dl vs bleeding: 8.2 ± 0.3 g/dl; P < 0.001). Both groups showed a highly significant decrease in INR values over time (reversal: 1.3 ± 0.2 at 180 ± 31 min after PCC application vs bleeding: 1.2 ± 0.2 at 147 ± 15 min after treatment; INR: P < 0.001 vs baseline, time: not significant). Creatinine and bilirubin concentrations at day 3 were not significantly increased in either group (P > 0.05), indicating no significant effect on renal and hepatic function.

Conclusion

Patients of the reversal group showed significant differences when compared with bleeding patients in terms of baseline INRs and cardiocirculatory situation (data not shown). Our results demonstrate that PCC can effectively improve INR in nonhypothermic surgical patients requiring coumarin reversal or experiencing severe bleeding. In almost all patients, this improvement in plasmatic coagulation was judged to be clinically significant, and allowed operative and/or interventional procedures.