TABLE 2.
Characteristics of Eligible Dabigatran Studies
| Reference | Setting | Range of Drug Concentration (ng/ml) | Test Material | Indication (n) | Dose (mg) | Coagulation Test | R2 |
|---|---|---|---|---|---|---|---|
| 10 | Germany | NR | Ex vivo patient plasma | MOS (287) | 12.5–300 BID; 150–300 QD | APTT ECT |
NR NR |
| 11 | Germany | NR | Ex vivo healthy volunteer plasma | NA (80) | 10–400 SD; 50–400 TID | APTT ECT PT/INR TT |
0.85 0.92–0.96 0.83–0.85 0.60–0.86 |
| 12 | Germany | NR | Ex vivo healthy volunteer plasma | NA (35) | 150 BID | APTT ECT |
NR NR |
| 13 | Sweden | 0–1000 | Spiked normal pooled plasma | NA (NA) | NA | APTT PT/INR |
NR NR |
| 14 | USA | 0–500 | Spiked normal pooled plasma | NA (NA) | NA | APTT Dilute TT TT |
0.95* 0.98 NR |
| 15 | USA, UK, Canada | 25–500 | Spiked normal pooled plasma | NA (NA) | NA | APTT PT/INR TT |
0.96 0.99 NR |
| 16 | Belgium | 4.7–943 | Spiked normal pooled plasma | NA (NA) | NA | APTT Dilute PT Dilute TT ECA ECT PiCT PT/INR TT |
0.96–0.99 NR 0.99 0.99 1.00 NR NR NR |
| 17 | Austria | 0–480 | Spiked normal pooled plasma | NA (NA) | NA | APTT PT/INR |
NR NR |
| 18 | Germany | 0–1000 | Spiked normal pooled plasma | NA (NA) | NA | APTT ECT PT/INR |
NR NR NR |
| 19 | New Zealand | 30–960 | Spiked normal pooled plasma | NA (NA) | NA | Dilute TT | NR |
| 20 | Germany | 0–1886 | Spiked normal pooled plasma | NA (NA) | NA | Dilute TT | 0.99 |
| 21 | Germany | 50–1400 | Spiked healthy volunteer plasma | NA (4) | NA | POC-INR PT/INR |
NR NR |
| 22 | Sweden | <0.5–586 | Ex vivo patient plasma | AF (70) | NR | APTT Dilute TT ECA PT/INR |
0.58 0.97 0.96 0.48 |
| 23 | USA | 0–500 | Ex vivo patient plasma Spiked normal pooled plasma |
AF (NR) VTE (NR) NA (NA) |
150 BID NA |
Dilute TT ECA |
0.96–0.97 0.99 |
| 24 | USA | 18–487 | Ex vivo patient plasma | AF (29) VTE (6) |
NR | ACT APTT Dilute TT ECA ECT PT/INR TT |
0.71 0.74–0.82 0.92 0.94–0.99 0.98 0.60–0.86 0.75–0.97 |
| 25 | Sweden | 0–985.5 | Spiked normal pooled plasma | NA (NA) | NA | PT/INR | NR |
| 26 | Finland | 120–300 | Spiked normal pooled plasma | NA (NA) | NA | APTT PT/INR TT |
NR NR NR |
*
Relationship described by second order polynomial regression.
ACT = activated clotting time; APTT = activated partial thromboplastin time; ECA = ecarin chromogenic assay; ECT = ecarin clotting time; INR = international normalized ratio; MOS = major orthopedic surgery; NA = not applicable; NR = not reported; PiCT = prothrombinase-induced clotting time; POC = point of care; PT = prothrombin time; SD = single dose; TT = thrombin time; VTE - venous thromboembolism; other abbreviations as in Table 1.