Table 2.
Comparison of on label and off label use of 4-factor prothrombin complex concentrate
| On label (n=131) | Off label (n=53) | P-value | |
|---|---|---|---|
| Sex, male | 78 (60) | 31 (58) | 1.00 |
| Age (yr) | 77 ± 11 | 60 ± 22 | < 0.001 |
| Antiplatelets | |||
| Aspirin | 67 (51) | 14 (26) | 0.003 |
| Clopidogrel | 16 (12) | 1 (2) | 0.03 |
| Comorbidities | |||
| Hypertension | 101 (77) | 31 (58) | 0.02 |
| Diabetes | 47 (36) | 12 (23) | 0.12 |
| Liver disease | 6 (5) | 10 (19) | 0.004 |
| CKD | 36 (27) | 6 (11) | 0.02 |
| Alcohol abuse | 3 (2) | 6 (11) | 0.02 |
| Prior bleeding episode | 15 (11) | 5 (9) | 0.80 |
| Prior stroke | 14 (11) | 5 (9) | 1.00 |
| Bleed site | |||
| Intracranial | 38 (29) | 15 (28) | 1.00 |
| Upper GI | 13 (10) | 6 (11) | 0.79 |
| Lower GI | 22 (17) | 6 (11) | 0.50 |
| Epistaxis | 3 (2) | 1 (92) | 1.00 |
| Hemothorax | 5 (4) | 1 (2) | 0.68 |
| Pelvic | 3 (2) | 1 (2) | 1.00 |
| Abdominal | 3 (2) | 3 (6) | 0.36 |
| Retroperitoneal | 5 (4) | 2 (4) | 1.00 |
| Extremities | 0 (0) | 4 (8) | 0.006 |
| Traumatic bleed | 33 (34) | 17 (44) | 0.33 |
| Treatments | |||
| Vitamin K | 92 (70) | 15 (28) | < 0.001 |
| FFP | 44 (34) | 26 (49) | 0.07 |
| PRBC | 63 (48) | 29 (55) | 0.52 |
| Platelets | 23 (18) | 26 (47) | < 0.001 |
| Factor IX | 1 (1) | 0 (0) | 1.00 |
| Factor VII | 0 (0) | 4 (8) | 0.006 |
| Cryoprecipitate | 5 (4) | 10 (19) | 0.002 |
| Interventions | |||
| None | 85 (65) | 26 (49) | 0.07 |
| Surgery | 31 (24) | 19 (36) | 0.10 |
| Interventional radiology | 9 (7) | 7 (13) | 0.25 |
| Hospital length of stay | 15 ± 27 | 20 ± 26 | 0.31 |
| In-hospital mortality | 25 (19) | 20 (38) | 0.01 |
Values are presented as number (%) or mean±standard deviation.
CKD, chronic kidney disease; GI, gastrointestinal; FFP, fresh frozen plasma; PRBC, packed red blood cells.