Table 2:
Haemostatic efficacy and rapid INR reduction by type of procedure (ITT-E population)
| 4F-PCC (n=87) |
Plasma (n=81) |
Treatment difference (95% CI)* | p value* | |||
|---|---|---|---|---|---|---|
| Endpoint achieved | Endpoint not achieved | Endpoint achieved | Endpoint not achieved | |||
| Haemostatic efficacy endpoint | ||||||
| Cranial neurosurgical | 0 | 1 (100%) | 1 (100%) | 0 | NA† | ·· |
| Cardiothoracic surgical | 3 (100%) | 0 | 3 (100%) | 0 | 0% | 1·00 |
| Major orthopaedic surgical | 16 (80%) | 4 (20%) | 9 (60%) | 6 (40%) | 20·0% (−9·6 to 47·0) | 0·27 |
| Other surgical | 46 (92%) | 4 (8%) | 35 (74%) | 12 (26%) | 17·5% (2·6 to 32·3) | 0·0279 |
| Invasive procedure | 13 (100%) | 0 | 13 (87%) | 2 (13%) | 13·3% (−11·4 to 37·9) | 0·48 |
| Rapid INR reduction endpoint (INR ≤1·3 at 0·5 h after end of infusion) | ||||||
| Cranial neurosurgical | 0 | 1 (100%) | 0 | 1 (100%) | NA† | ·· |
| Cardiothoracic surgical | 2 (67%) | 1 (33%) | 0 | 3 (100%) | 66·7% (−5·9 to 93·9) | 0·4 |
| Major orthopaedic surgical | 11 (55%) | 9 (45%) | 2 (13%) | 13 (87%) | 41·7% (9·5 to 63·1) | 0·0158 |
| Other surgical | 27 (54%) | 23 (46%) | 2 (4%) | 45 (96%) | 49·7% (32·9 to 63·1) | <0·0001 |
| Invasive procedure | 8 (62%) | 5 (38%) | 4 (27%) | 11 (73%) | 34·9% (−1·4 to 60·9) | 0·12 |
Treatment difference refers to between-group difference of 4F-PCC minus plasma. Endpoint achieved refers to effective haemostasis or rapid reduction in INR; endpoint not achieved refers to non-effective haemostasis or no rapid reduction in INR. 4F-PCC=four-factor prothrombin complex concentrate. ITT-E=intention-to-treat efficacy. NA=not available.
*
95% CIs and p values generated post hoc using a basic χ2 test for homogeneity (Fisher’s exact test used for small cell sizes).
†
Analysis not done because fewer than five patients were in this subgroup.