TABLE 1.
Summary of the effects of oritavancin on coagulation test results determined in vitroa
| Coagulation test | Reagent | Assay measurement units | Normal reference range | Mean ± SD (% change relative to control) at the indicated oritavancin concn |
|||||
|---|---|---|---|---|---|---|---|---|---|
| Control | 2.1 μg/ml | 5.4 μg/ml | 8.3 μg/ml | 15.9 μg/ml | 46.6 μg/ml | ||||
| Phospholipid dependent | |||||||||
| PT/INR | STA-Neoplastine CI Plus | s | 11.9–14.1 | 13.2 ± 0.17 | 13.2 ± 0.16 (0) | 13.2 ± 0.13 (0) | 13.2 ± 0.11 (0) | 13.4 ± 0.13 (1.4) | 13.7 ± 0.11 (3.6) |
| HemosIL RecombiPlasTin 2G | s | 9.4–12.5 | 12.1 ± 0.11 | 12.1 ± 0.14 (0.2) | 12.2 ± 0.10 (1.1) | 12.3 ± 0.15 (1.9) | 12.4 ± 0.16 (2.3) | 13.2 ± 0.18 (8.9) | |
| Dade Innovin | s | 9.9–11.8 | 11.0 ± 0.06 | 11.0 ± 0.06 (0) | 11.1 ± 0.07 (0.6) | 11.1 ± 0.05 (1.0) | 11.3 ± 0.12 (2.5) | 11.8 ± 0.07 (7.0) | |
| aPTT | STA-PTTa | s | 23.4–36.4 | 31.8 ± 0.40 | 31.7 ± 0.35 (−0.2) | 32.5 ± 0.72 (2.2) | 33.3 ± 0.63 (5.0) | 36.3 ± 0.54 (14.4) | 59.8 ± 2.28 (88.3) |
| HemosIL SynthASil | s | 25.1–36.5 | 31.7 ± 0.28 | 32.0 ± 0.16 (0.9) | 32.2 ± 0.19 (1.5) | 32.7 ± 0.20 (3.3) | 34.1 ± 0.19 (7.6) | 42.5 ± 0.58 (34.2) | |
| Dade Actin FSL | s | 25.3–33.8 | 29.5 ± 0.61 | 29.5 ± 0.25 (−0.2) | 29.6 ± 0.28 (0.2) | 29.7 ± 0.30 (0.7) | 30.4 ± 0.50 (2.8) | 39.8 ± 0.85 (34.8) | |
| DRVVT | LA Check/LA Sure | s | <55.1 | 43.2 ± 1.07 | 43.6 ± 0.98 (0.9) | 43.4 ± 1.06 (0.5) | 44.3 ± 0.90 (2.6) | 44.8 ± 0.93 (3.7) | 53.6 ± 1.72 (24.0) |
| APCR | COATEST APC Resistance V | APC ratio | 2.2–4.0 | 2.3 ± 0.11 | 2.3 ± 0.11 (0) | 2.3 ± 0.10 (1.3) | 2.3 ± 0.11 (1.7) | 2.3 ± 0.09 (2.2) | 2.4 ± 0.13 (3.1) |
| Phospholipid independent | |||||||||
| Anti-FXa | STA-Rotachrom heparin | IU/ml | LLOQ = 0.10 IU/ml | <LLOQ | <LLOQ | <LLOQ | <LLOQ | <LLOQ | <LLOQ |
| TT | STA-Thrombin | s | <20.0 | 15.6 ± 0.21 | 15.6 ± 0.18 (0.3) | 15.8 ± 0.27 (1.2) | 15.7 ± 0.15 (1.0) | 15.7 ± 0.24 (0.9) | 15.7 ± 0.33 (0.9) |
| Anti-heparin-PF4 | Asserachrom HPIA | Normalized OD ratio | <0.8 | Negativeb | Negative | Negative | Negative | Negative | Negative |
| D dimer | STA-Liatest D-Di | μg/ml FEU | <0.5 μg/ml FEU | 0.21 ± 0.04 | 0.25 ± 0.04 (19.0) | 0.22 ± 0.05 (4.8) | 0.25 ± 0.05 (19.0) | 0.25 ± 0.04 (19.0) | 0.29 ± 0.04 (38.1) |
a
Anti-FXa, anti-factor Xa; APCR, activated protein C resistance; aPTT, activated partial thromboplastin time; DRVVT, dilute Russell's viper venom time; FEU, fibrinogen equivalent units; LLOQ, lower limit of quantitation; PT/INR, prothrombin time/international normalized ratio; TT, thrombin time.
b
Negative, a normalized optical density ratio of <0.8 is indicative of negativity for heparin-induced platelet antibodies.