Use of prothrombin complex concentrate for excessive bleeding after cardiac surgery

Abstract

Objectives: Prothrombin complex concentrates (PCCs) are sometimes used as 'off label' for excessive bleeding after cardiopulmonary bypass (CPB). The main objective of this study was to retrospectively evaluate the clinical and biological efficacy of PCC in this setting.

Methods: We reviewed the charts of all patients who had undergone cardiac surgery under CPB in our institution for 2 years. Patients treated for active bleeding with haemostatic therapy were identified. Chest tube blood loss was quantified postoperatively in the first 24 h. Coagulation parameters were recorded at intensive care unit admission and in the patient's first 24 h. Thromboembolic complications were also ascertained.

Results: Seventy-seven patients out of the 677 studied (11.4%) were included: PCC was solely administered in 24 patients (group I), fresh frozen plasma in 26 (group II) and both in 27 (group III). The mean dose of PCC was 10.0 UI/kg ± 3.5 for group I vs 14.1 UI/kg ± 11.2 for group III (P = 0.09). Initial blood loss in the first hour was different between the three groups (P = 0.05): 224 ± 131 ml for group I, 369 ± 296 ml for group II and 434 ± 398 ml for group III. Only group I vs group III presented a significant difference (P = 0.02). Variations of blood loss over time were no different according to the treatment groups (P = 0.12). Reductions in blood loss expressed in percentage showed no difference between the three groups after 2 h: 54.5% (68.6-30.8) for group I; 45.0% (81.6-22.2) for group II; 57.6 (76.0-2.1) for group III; (P = 0.89). Re-exploration for bleeding involved 1 patient in group I (4%), 2 in group II (8%) and 10 in group III (37%) (P = 0.002). Except for fibrinogen, variations of prothrombin time, activated partial thromboplastin time and platelets with time were not different according to the treatment groups. Cerebral infarction occurred in one patient in group II.

Conclusions: Administration of low-dose of PCC significantly decreased postoperative bleeding after CPB.

Figure 1:

Course of chest tube blood loss. Initial blood loss at H1 was different between the three groups (P = 0.05). Only group I vs group III presented a significant difference (P = 0.05) for blood loss at H1. Variations of blood loss over time were not different according to the treatment groups (P = 0.12). Decrease in blood loss was significantly different between H1 and H2 (P < 0.0001). After H2, no significant changes were demonstrated: P = 0.16 between H2 and H4.

Figure 2:

Timing of administration of haemostatic treatment in the immediate postoperative period. PCC: prothrombin complex concentrates; FFP: fresh frozen plasma, RBC: red blood cells.

Figure 3:

Course of biological parameters. T1: at ICU admission; T2: 6 h ± 4 after ICU admission; T3: 11 h ± 5 after ICU admission; T4: 24 h after ICU admission. Red boxes: prothrombin complex concentrates (group I); White box: fresh frozen plasma (group II); blue boxes: prothrombin complex concentrates and fresh frozen plasma (group III). Prothrombin time (PT). Course of PT varied over time: *T1 vs T3 (P = 0.008); ^†T1 vs T4 (P < 0.0001); ^‡T2 vs T3 (P = 0.05); ^#T2 vs T4 (P = 0.0001); **T3 vs T4 (P = 0.006). Variations of PT over time were not different according to the treatment groups. There was no difference between groups for PT. Activated partial thromboplastin time (aPTT). Course of aPTT did not vary over time. Variations of aPPT over time were not different according to the treatment groups. Values of aPTT were different between group I vs group II (P = 0.04). Platelet count. Course of platelet count did not vary over time. Variations of platelet count with time were not different according to the treatment groups. There was no difference between groups for platelet count. Fibrinogen. Course of fibrinogen varied over time: *T1 vs T3 (P < 0.0001); ^†T1 vs T4 (P < 0.0001); ^‡T2 vs T3 (P < 0.0001); ^#T2 vs T4 (P < 0.0001); **T3 vs T4 (P < 0.0001). Variations of fibrinogen over time were different according to the treatment groups (P < 0.0001). Values of fibrinogen were different between group I vs group III (P = 0.03).