Table 2.
Outcomes by sex and randomized treatment arm for patients enrolled in the PROPPR trial (N=680).
| Males | Females | |||||
|---|---|---|---|---|---|---|
| Characteristic | Overall (N = 546) |
1:1:1 Arm (N = 263) |
1:1:2 Arm (N = 283) |
Overall (N = 134) |
1:1:1 Arm (N = 75) |
1:1:2 Arm (N = 59) |
| 24-hour mortality, n (%) | 77 (14%) | 30 (11%) | 47 (17%) | 23 (17%) | 12 (16%) | 11 (19%) |
| 30-day mortality, n (%) | 124 (23%) | 51 (20%) | 73 (26%) | 40 (30%) | 24 (32%) | 16 (27%) |
| 24-hour exsanguination, n (%) | 65 (12%) | 22 (8.4%) | 43 (15%) | 16 (12%) | 9 (12%) | 7 (12%) |
| 30-day exsanguination, n (%) | 68 (13%) | 25 (9.6%) | 43 (15%) | 18 (13%) | 11 (15%) | 7 (12%) |
| Achieved Hemostasis, n (%) | 447 (82%) | 227 (86%) | 220 (78%) | 110 (82%) | 64 (85%) | 46 (78%) |
| Time to Hemostasis, min, median (IQR) | 136 (93–208.5) | 143 (95–206.5) | 128.5 (90–209.2) | 146.5 (94–244.8) | 153 (102–247.5) | 137.5 (89–227.8) |
| Massive transfusion, n (%) | 216 (40%) | 98 (37%) | 118 (42%) | 53 (40%) | 35 (47%) | 18 (31%) |
| Critical administration threshold, n (%) [N=678] | 481 (88%) | 219 (84%) | 262 (93%) | 114 (85%) | 62 (83%) | 52 (88%) |
| Pre-Randomization Plasma, median (IQR) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) |
| Pre-Randomization Platelets, median (IQR) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) | 0 (0–0) |
| Pre-Randomization RBC, median (IQR) | 2 (1–2) | 2 (1–2) | 2 (1–2) | 2 (1–3) | 2 (2–3) | 2 (1–2) |
| Pre-Hemostasis Plasma, median (IQR) | 3 (2–8) | 5 (2–9) | 3 (1–6.5) | 3.5 (2–7) | 5 (2–14) | 3 (1–5) |
| Pre-Hemostasis Platelets, median (IQR) | 6 (0–12) | 6 (6–12) | 6 (0–6) | 6 (6–12) | 6 (6–18) | 6 (0–6) |
| Pre-Hemostasis RBC, median (IQR) | 6 (3–12) | 5 (2–10) | 6 (4–13.5) | 6 (3–11) | 6 (3–13.5) | 6 (3–9.5) |
| Post-Hemostasis Plasma, median (IQR) | 0 (0–2) | 0 (0–2) | 1 (0–3) | 0 (0–2) | 0 (0–2) | 0 (0–4) |
| Post-Hemostasis Platelets, median (IQR) | 0 (0–6) | 0 (0–0) | 0 (0–6) | 0 (0–6) | 0 (0–6) | 0 (0–6) |
| Post-Hemostasis RBC, median (IQR) | 0 (0–2) | 0 (0–2) | 0 (0–2) | 0 (0–2) | 0 (0–2) | 0 (0–2) |
RBC, Red Blood Cell. Samples sizes are equal to 680 for 24-hour mortality and hemostasis, 676 for 30-day mortality and 30-day exsanguination, 621 for post-hemostasis blood product variables, and 557 for time to hemostasis.