Table 1.
Study characteristics
| Reference | Range of drug concentration (ng/mL) | Test material | Dose (mg) | Coagulation test (reagent) | R 2 |
|---|---|---|---|---|---|
| Zafar et al. 2007 [10] | 34 to 256 | Ex vivo healthy volunteer plasma | 60 SD | APTT (NR) | 0.40 |
| PT (NR) | 0.79 | ||||
| Anti-Xa (STA-Rotachrom) | 0.85 | ||||
| Furugohri et al. 2008 [11] | NR | Spiked normal plasma | NA | APTT (Platelin LS) | NR |
| PT (Thromboplastin C Plus) | NR | ||||
| TT (Calbiochem human thrombin) | NR | ||||
| Anti-Xa (Chromogenix) | NR | ||||
| Ogata et al. 2010 [4] | 0 to > 1200 | Ex vivo healthy volunteer plasma | Variousa | APTT (Hemochron Jr.) | 0.89 |
| PT (NR) | 0.94–0.96 | ||||
| Anti-Xa (NR) | 0.96 | ||||
| Mendell et al. 2011 [12] | 9 to 567 | Ex vivo healthy volunteer plasma | 60 SD | APTT (NR) | NR |
| PT (NR) | NR | ||||
| Wolzt et al. 2011 [13] | 0 to > 600 | Ex vivo healthy volunteer plasma | 30, 60, or 120 SD | APTT (STA aPTT) | 0.74 |
| PT (STA Neoplastin Plus) | 0.96 | ||||
| Anti-Xa (STA-Rotachrom) | 0.96 | ||||
| Fukuda et al. 2012 [14] | 150 to 300 | Spiked normal plasma | NA | PT (Thromboplastin C Plus) | NR |
| Samama et al. 2012 [15] | 0 to 500 | Spiked normal plasma | NA | APTT (PTT-A) | NR |
| APTT (CK-Prest) | NR | ||||
| APTT (PTT-LA) | NR | ||||
| APTT (Actin FS) | NR | ||||
| PT (Neoplastin) | NR | ||||
| PT (Neoplastin Plus) | NR | ||||
| PT (TriniCLOT) | NR | ||||
| PT (RecombiPlasTin) | NR | ||||
| PT (Innovin) | NR | ||||
| PT (Thromborel S) | NR | ||||
| Anti-Xa (Rotachrom HBPM) | 0.99 | ||||
| Anti-Xa (Factor Xa inhibitors) | 0.99 | ||||
| PiCT (PiCT activator reagent) | NR | ||||
| DRVVT (American Diagnostica) | 0.97 | ||||
| Mendell et al. 2013 [16] | NR | Ex vivo healthy volunteer plasma | 60 QD × 5 days | Anti-Xa (STA-Rotachrom) | >0.95 |
| Noguchi et al. 2014 [17] | 0 to 720 | Spiked normal plasma | NA | APTT (Actin-activated cephaloplastin) | NR |
| PT (Thromborel S) | NR |
APTT activated partial thromboplastin time, DRVVT dilute Russell viper venom time, INR international normalized ratio, NA not applicable, NR not reported, PiCT prothrombinase-induced clotting time, PT prothrombin time, SD single dose, TT thrombin time
a
10, 30, 60, 90, 120, 150 SD; 90, 120 QD × 10 days; 60 BID × 10 days