Table 2.
Outcomes for Phase 1
| Variable | Total | Control Group | tPA Bolus + Heparin Group | P Value |
|---|---|---|---|---|
| No. | 36 | 17 | 19 | ... |
| Pao2 to Fio2 ratio | ||||
| At 24 h | 145.0 (110.5-193.5) | 146.7 (98.8-174.0) | 144.0 (122.9-217.1) | .5471 |
| % Improvement over baseline at 24 h | 39.7 (–4.9 to 72.1) | 37.0 (–6.4 to 64.5) | 44.4 (–3.4 to 78.0) | .6573 |
| At 48 h | 138.2 (105.0-181.0) | 125.0 (87.5-147.5) | 157.1 (130.0-188.0) | .0458 |
| % Improvement over baseline at 48 h | 24.6 (–1.5 to 59.8) | 16.9 (–8.3 to 36.8) | 29.8 (4.5-88.7) | .1131 |
| Composite outcome: Pao2 to Fio2 ratio % improvement at 48 h of > 50% or Pao2 to Fio2 ratio of ≥ 200 | 11 (30.6) | 2 (11.8) | 9 (47.4) | .0312 |
| Paralytics at 48 h | 18 (50.0) | 10 (58.8) | 8 (42.1) | .5051 |
| Position at 48 h | .8166 | |||
| Prone | 14 (38.9) | 6 (35.3) | 8 (42.1) | |
| Supine | 16 (44.4) | 9 (52.9) | 7 (36.8) | |
| Left side | 2 (5.6) | 1 (5.9) | 1 (5.3) | |
| Right side | 4 (11.1) | 1 (5.9) | 3 (15.8) | |
| NEWS2 score % increase over baseline at 48 h | 0.0 (–22.2 to 30.0) | 0.0 (–22.2 to 40.0) | 0.0 (–22.2 to 20.0) | .9241 |
| PTT, s | ||||
| At 24 h | 38.9 (32.7-58.6) | 32.9 (28.0-36.1) | 51.7 (36.9-65.6) | .0004 |
| At 48 h | 41.2 (30.0-65.6) | 30.0 (26.9-36.2) | 64.3 (55.7-73.6) | < .0001 |
| INR | ||||
| At 24 h | 1.2 (1.1-1.3) | 1.3 (1.2-1.3) | 1.2 (1.1-1.2) | .1521 |
| At 48 h | 1.2 (1.1-1.3) | 1.2 (1.1-1.3) | 1.2 (1.1-1.3) | .5685 |
| Fibrinogen, mg/dL | ... | ... | ... | ... |
| At 24 h | 613.0 (562.0-814.0) | 595.0 (521.0-828.0) | 627.0 (567.0-800.0) | .7513 |
| At 48 h | 586.0 (498.0-798.0) | 612.0 (450.0-817.0) | 567.0 (520.0-786.0) | .9725 |
| D-dimer, ng/mL | ||||
| At 24 h | 1,895.0 (969.0-4,422.0) | 1,426.0 (730.0-3,970.0) | 2,296.0 (1,330.0-9,700.0) | .0615 |
| At 48 h | 1,641.0 (900.0-3,450.0) | 1,326.0 (870.0-2,970.0) | 1,975.0 (1,010.0-3,650.0) | .4282 |
| Adverse event incidence | 26 (72.2) | 13 (76.5) | 13 (68.4) | .7169 |
| Bleeding event incidence | 5 (13.9) | 2 (11.8) | 3 (15.8) | 1.000 |
| Ventilation days | 14.0 (9.0-28.0) | 18.0 (9.0-28.0) | 13.0 (8.0-25.0) | .2088 |
| VFD | 0.0 (0.0-17.0) | 0.0 (0.0-9.0) | 12.0 (0.0-19.0) | .1064 |
| ICU days | 16.5 (11.5-28.0) | 18.0 (12.0-28.0) | 16.0 (11.0-28.0) | .8990 |
| IFD | 0.0 (0.0-14.0) | 0.0 (0.0-10.0) | 6.0 (0.0-15.0) | .4200 |
| Mortality | ||||
| In-hospital | 11 (30.6) | 7 (41.2) | 4 (21.1) | .1907 |
| 28-d | 9 (25.0) | 5 (29.4) | 4 (21.1) | .5631 |
Data are presented as No., No. (%), or median (interquartile range). IFD = ICU-free day; INR = international normalized ratio for prothrombin time; NEWS2 = National Early Warning System 2; PTT = partial thromboplastin time; tPA = tissue plasminogen activator; VFD = ventilation-free day.