Table 3.
Effectiveness and Interventions According to Treatment and PCC Dose: (A) Prophylactic Cohort and (B) Treatment Cohort.
| (A) Prophylactic Cohort | ||||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | PCC Dose (Recipients of PCC Only)a | P valueb | PCC Dose (Recipients of PCC and FFP) | P valueb | ||||
| 10-19.9 IU/kg | ≥20 IU/kg | 10-19.9 IU/kg (Median FFP dose, 1093 mL) | ≥20 IU/kg (Median FFP dose, 1625 mL) | |||||
| Number of patients | 7 | 9 | 1 | 4 | ||||
| Baseline INR, median (IQR) | 1.6 (1.4,1.7) | 1.9 (1.8, 1.9) | .13 | 2.1 (2.1, 2.1) | 2.3 (1.8, 3.0) | NC | ||
| Adequate Effectivenessc | 7 (100%) | 7 (100%)d | 1.00 | -d | 4 (100%) | NC | ||
| Any blood product transfusion | 4 (57%) | 4 (44%) | 1.00 | 1 (100%) | 4 (100%) | NC | ||
| Platelets | ||||||||
| Recipients, n (%) | 4 (57%) | 2 (22%) | .30 | 1 (100%) | 2 (50%) | NC | ||
| Median dose (IQR) | 1 (0, 2) | 0 (0, 0) | .14 | 4 (4, 4) | 1 (0, 3) | NC | ||
| Red blood cells | ||||||||
| Recipients, n (%) | 1 (14%) | 2 (22%) | 1.00 | 1 (100%) | 3 (75%) | NC | ||
| Median dose (IQR) | 0 (0, 0) | 0 (0, 0) | .82 | 3 (3, 3) | 2 (1, 4) | NC | ||
| FFP | ||||||||
| Recipients, n (%) | 0 (0%) | 0 (0%) | 1.00 | 1 (100%) | 4 (100%) | NC | ||
| Median dose (IQR) | 0 (0, 0) | 0 (0, 0) | 1.00 | 4.0 (4.0, 4.0) | 5.9 (3.8, 8.7) | NC | ||
| Cryoprecipitate | ||||||||
| Recipients, n (%) | 0 (0%) | 0 (0%) | 1.00 | 0 (0%) | 0 (0%) | NC | ||
| Median dose (IQR) | 0 (0, 0) | 0 (0, 0) | 1.00 | 0 (0, 0) | 0 (0, 0) | NC | ||
| (B) Treatment Cohort | ||||||||
| PCC Dose (Recipients of PCC Only) | P Valueb | PCC dose (Recipients of PCC and FFP) | P Valueb | |||||
| Parameter | <10 IU/kg | 10-19.9 IU/kg | ≥20 IU/kg | <10 IU/kg (Median FFP dose, 550 mL) | 10-19.9 IU/kg (Median FFP dose, 544 mL) | ≥20 IU/kg (Median FFP dose, 560 mL) | ||
| Number of patients | 113 | 89 | 26 | 32 | 59 | 32 | ||
| Baseline INR, median (IQR) | 1.5 (1.4, 1.7) | 1.5 (1.4, 1.7) | 1.5 (1.4, 1.7) | .33 | 1.5 (1.4, 1.7) | 1.7 (1.5, 1.9) | 1.4 (1.2, 2.4) | .12 |
| Adequate Effectivenessc | 107 (95%) | 83 (93%) | 23 (88%) | .48 | 26 (81%) | 51 (86%) | 20 (63%) | .03 |
| Any blood product transfusion | 50 (45%) | 58 (67%) | 22 (88%) | <.001 | 21 (72%) | 51 (93%) | 30 (94%) | .03 |
| Platelets | ||||||||
| Recipients, n (%) | 39 (35%) | 50 (56%) | 20 (77%) | <.001 | 21 (70%) | 51 (88%) | 30 (94%) | .03 |
| Median dose (IQR) | 0 (0, 1) | 1 (0, 2) | 1 (1, 2) | <.001 | 2 (0, 2) | 2 (1, 2) | 3 (2, 3) | <.001 |
| Red blood cells | ||||||||
| Recipients, n (%) | 33 (29%) | 40 (45%) | 13 (52%) | .02 | 14 (45%) | 40 (68%) | 25 (78%) | .02 |
| Median dose (IQR) | 0 (0, 1) | 0 (0, 2) | 1 (0, 3) | .02 | 0 (0, 2) | 2 (0, 4) | 2 (1, 7) | .004 |
| FFP | ||||||||
| Recipients, n (%) | 0 (0%) | 0 (0%) | 0 (0%) | 1.00 | 32 (100%) | 59 (100%) | 32 (100%) | 1.00 |
| Median dose (IQR) | 0 (0, 0) | 0 (0, 0) | 0 (0, 0) | 1.00 | 2.0 (1.4, 2.4) | 2.0 (1.9, 2.9) | 2.0 (2.0, 4.0) | .02 |
| Cryoprecipitate | ||||||||
| Recipients, n (%) | 5 (4%) | 15 (17%) | 13 (50%) | <.001 | 5 (16%) | 21 (38%) | 22 (69%) | <.001 |
| Median dose (IQR) | 0 (0, 0) | 0 (0, 0) | 0.5 (0, 2) | <.001 | 0 (0, 0) | 0 (0, 1) | 2 (0, 2) | <.001 |
Abbreviations: FFP, fresh frozen plasma; IQR, interquartile range; NC, not calculated; PCC, prothrombin complex concentrate.
aIn the prophylactic cohort, no patients received PCC at a dose below 10 IU/kg.
b P values are for differences between dose groups.
cAdequate effectiveness defined as very good or satisfactory effectiveness in prevention/stopping of bleeding (physician’s judgment).
dTwo missing values ≥20 IU/kg group for PCC only patients, and 1 missing value for 10 to 19.9 IU/kg for PCC and FFP patients.