Table 1.
Baseline characteristics of study population
| Placebo (n = 25) | FC (n = 28) | Estimated difference (95% CI) | P | |
| Age (years) | 54 [37 to 56] | 46 [34.5 to 58] | 4 (−6 to 13) | 0.4868 |
| Female | 4/25 (16.0%) | 5/28 (17.9%) | 0.88 (0.15 to 4.70) | 1 |
| Male | 21/25 (84.0%) | 23/28 (82.1%) | 0.88 (0.15 to 4.70) | 1 |
| BMI (kg m−2) | 26.3 [24.7 to 28.09] | 25.0 [23.4 to 27.5] | 1.28 (−0.56 to 2.94) | 0.1538 |
| ISS | 16 [16 to 34] | 25 [16 to 36] | −3 (−16 to 4) | 0.3937 |
| GCS | 15 [13 to 15] | 14.5 [6 to 15] | 0 (0 to 3) | 0.574 |
| Craniocerebral injury | 5/25 (20.0%) | 11/28 (39.3%) | 2.54 (0.65 to 11.31) | 0.1474 |
| Intubation at the scene | 5/25 (20.0%) | 11/28 (39.3%) | 2.54 (0.65 to 11.31) | 0.1474 |
| Prehospital TXA | 9/25 (36%) | 3/28 (10.7%) | 0.22 (0.03 to 1.05) | 0.0471 |
| Vital signs | ||||
| SBP (mmHg) | 90 [85 to 120] | 100 [80 to 112] | 0 (−15 to 12) | 0.9501 |
| Heart rate (beats min−1) | 100 [90 to 120] | 110 [99 to 119.5] | 0 (−15 to 10) | 0.6186 |
| Laboratory measurements | ||||
| pH | 7.34 [7.28 to 7.37] | 7.29 [7.26 to 7.36] | 0.03 (−0.02 to 0.08) | 0.2702 |
| BD (mmol l−1) | 2.5 [−0.3 to 4.2] | 3.0 [1.8 to 5.5] | −1.09 (−3.2 to 0.9) | 0.3064 |
| Lactate (mmol l−1) | 0.97 [0.72 to 1.60] | 1.28 [0.72 to 2.33] | −0.19 (−1.22 to 0.39) | 0.5453 |
| Haemoglobin (g l−1) | 137 [127 to 152] | 141 [130 to 147] | 0 (−10 to 10) | 0.9923 |
| PT quick, % | 90 [79 to 97] | 89 [68 to 96.25] | 3 (−6 to 17) | 0.4711 |
| aPTT (s) | 27 [24 to 29] | 26 [25 to 30] | −1 (−3.0 to 1.4) | 0.4496 |
| Fibrinogen (g l−1) | 235 [208 to 259] | 248 [184.75 to 272] | −6 (−38 to 35) | 0.6854 |
| Antithrombin, % | 86 [78 to 93] | 83 [73 to 94] | 4 (−3 to 11) | 0.2898 |
| FXIII, % | 118 [98 to 130] | 114 [98.25 to 130] | 0 (−11 to 16) | 0.9312 |
| vWF antigen, % | 245 [201 to 298] | 242 [194.25 to 301] | 0 (−32 to 35) | 0.8 |
| vWF ristocetin cofactor, % | 269 [215 to 301] | 259 [203.75 to 301] | 0 (−17 to 38) | 0.9255 |
| Platelet count (x109 l−1) | 239 [191 to 270] | 242 [209 to 271] | −13 (−47 to 17) | 0.3416 |
| ROTEM | ||||
| FIBMCF (mm) | 13 [10 to 15] | 13 [9 to 16.5] | 0 (−3 to 2) | 0.7817 |
| EXTEM CT (s) | 50 [46 to 61] | 62 [52 to 68.5] | −9 (−16 to −1) | 0.031 |
| EXTEM CFT (s) | 104 [90 to 118] | 96.5 [78.25 to 128.25] | 8 (−12 to 23) | 0.3449 |
| EXTEM MCF (mm) | 58 [56 to 62] | 58.5 [53 to 64.25] | 0 (−4 to 4) | 0.9218 |
| EXTEM L60, % | 94 [91.75 to 98] | 93 [91 to 96] | 1 (−2 to 3) | 0.6838 |
| INTEM CT (s) | 136 [129 to 149] | 141.5 (128.5 to 150.25] | −3.07 (−14 to 8) | 0.6558 |
| INTEM CFT (s) | 82 [67 to 96] | 86 [64.75 to 114.5] | −2.34 (−20 to 14) | 0.7148 |
| INTEM L60, % | 92 [91 to 96.25] | 94 [92 to 96] | −1 (−3 to 1) | 0.506 |
| INTEM MCF (mm) | 58 [55 to 61] | 56 [51 to 62] | 1 (−3 to 5) | 0.6169 |
| APTEM CT (s) | 56 [48.5 to 71.5] | 60 [53.5 to 72] | −4 (−12 to 5) | 0.422 |
| APTEM CFT (s) | 108.5 [95.25 to 125.5] | 96 [84 to 129.5] | 10 (−11 to 23) | 0.2654 |
| APTEM MCF (mm) | 58 [55 to 61.25] | 58 [54 to 64] | 0 (−4 to 3) | 0.8351 |
| APTEM L60, % | 93.5 [92.75 to 98] | 93 [92 to 96] | 1 (−1 to 3) | 0.4325 |
Values in Placebo and FC groups are median [IQR] or number (%).
aPTT, activated partial thromboplastin time; EP, emergency personnel; ER, emergency room; FC, fibrinogen concentrate; FXIII, factor XIII; GCS, Glasgow coma scale; ISS, injury severity score; TXA, tranexamic acid; vWF, von Willebrand factor.