Table 1 Summaries of RCTs and observational studies on rTM
Summary of RCTs | |||||
Disease | Source | Intervention | Mortality (%) | Resolution of DIC | |
rTM | Control | ||||
Sepsis | Aikawa et al. [35] | 0.06 mg/kg/day for 6 days (n = 42) | UFH (n = 38) | 21.4% vs 31.6% | 73.2% vs 63.2% |
Vincent et al. [36] | 0.06 mg/kg/day for 6 days (n = 370) | Placebo (n = 371) | 17.8% vs 21.6% | 28.9% vs 18.9% (day 1) | |
Hagiwara et al. [97] | 0.06 mg/kg/day up to 6 days (n = 45) | w/o rTM (n = 47) | 17.0% vs 15.6% | *90.7% vs 65.9% | |
Vincent et al. [4] | 0.06 mg/kg/day for 6 days (n = 395) | Placebo (n = 405) | 26.8% vs 29.4% | N/A | |
Hemotologic malignancy | Saito et al., [3] | 0.06 mg/kg/day for 6 days (n = 64) | UFH (n = 61) | 17.2% vs 18.0% | *65.6% vs 45.9% |
Summary of observational studies | |||||
Disease | Source | Intervention | Results (95% CI) | ||
rTM | Control | ||||
Sepsis | Ohryoji et al. [38] | 0.06 mg/kg/day for 6 days (n = 17) | w/o rTM (n = 16) historical control | Mortality rate 23.5% vs 50.0% | |
Yada et al. [38] | 0.06 mg/kg/day for 6 days (n = 12) | w/o rTM (n = 16) | 30-day mortality rate 25.0% vs 18.8% | ||
Kudo et al. [38] | 0.06 mg/kg/day for 6 days (n = 30) | w/o rTM (n = 23) historical control | 30-day mortality rate *10.0% vs 34.8% | ||
Umegaki et al. [38] | 0.06 mg/kg/day for 7 days (n = 33) | Danaparoid (n = 40) historical control | 28-day mortality HR 0.72 (0.31–1.66) | ||
Yamakawa et al. [98] | 0.06 mg/kg/day for 6 days (n = 68) | w/o rTM (n = 94) | In-hospital mortality *HR 0.45 (0.26–0.77) | ||
Kato et al. [99] | 0.06 mg/kg/day for 7 days (n = 12) | w/o rTM (n = 23) | 28-day mortality *HR 0.384 (0.088–0.904) | ||
Sawano et al. [38] | 0.06 mg/kg/day for 6 days (n = 51) | w/o rTM (n = 60) | 28-day mortality *HR 0.28 (0.11–0.72) | ||
Yamato et al. [100] | 0.06 mg/kg/day for 6 days (n = 14) | w/o rTM (n = 8) historical control | 28-day mortality rate *14.3% vs 62.5% | ||
Tagami et al. [39] | 0.06 mg/kg/day for 6 days (n = 1140) | w/o rTM (n = 1140) | 28-day mortality OR 1.01 (0.93–1.10) | ||
Hayakawa et al. [42] | 0.06 mg/kg/day for 6 days (n = 452) | w/o rTM (n = 452) | In-hospital mortality *OR 0.757 (0.574–0.999) | ||
AML | Takezako et al. [55] | 0.06 mg/kg/day for 6 days (n = 14) | LMWH (n = 33) | Estimated overall survival *Superior in rTM | |
AE of IPF | Kataoka et al. [81] | 0.06 mg/kg/day for 6 days (n = 20) | w/o rTM (n = 20) historical control | 3-month mortality *OR 0.219 (0.049–0.978) | |
Sakamoto et al. [82] | 0.06 mg/kg/day for 6 days (n = 45) | w/o rTM (n = 35) historical control | 3-month mortality *OR 0.250 (0.091–0.685) | ||
AE of IIP | Arai et al. [83] | 0.06 mg/kg/day for 6 days (n = 39) | w/o rTM (n = 61) historical control | 90-day mortality *HR 0.453 (0.237–0.864) | |