Table 2.
Primary and key secondary outcomes
| Packed red blood cells and lyophilised plasma group | 0·9% sodium chloride group | Adjusted risk ratio (95% CI) | Adjusted average difference (95% CI) | |
|---|---|---|---|---|
| Primary outcome | ||||
| Episode mortality or failure to clear lactate, or both | 128/199 (64%) | 136/210 (65%) | 1·01 (0·88 to 1·17)*; p=0·86 | −0·025% (−9 to 9)†; p=1·00 |
| Secondary outcomes | ||||
| Episode mortality | 88/203 (43%) | 99/218 (45%) | 0·97 (0·78 to 1·20)*; p=0·75 | −3% (−12 to 7)†; p=0·57 |
| Failure to clear lactate | 98/196 (50%) | 113/206 (55%) | 0·94 (0·78 to 1·13)*; p=0·52 | −5% (−14 to 5)†; p=0·33 |
| Post-intervention fluids, mL | 123 (310), 207 | 160 (389), 221 | .. | −34 (−101 to 32)‡; p=0·31 |
| Time to ED arrival, mins | ||||
| From 999 call | 90 (35) | 91 (35) | .. | 0·60 (−6·14 to 7·35)‡; p=0·86 |
| From randomisation | 37 (22) | 35 (22) | .. | 3·03 (−1·40 to 7·46)‡; p=0·18 |
| Vital signs at ED arrival | ||||
| Heart rate, bpm | 107 (29) | 105 (24) | .. | −0·80 (−5·83 to 4·23)§; p=0·76 |
| Systolic blood pressure, mm Hg | 114 (27) | 114 (29) | .. | −1·19 (−8·19 to 5·82)§; p=0·74 |
| Diastolic blood pressure, mm Hg | 75 (24) | 72 (24) | .. | 2·26 (−3·77 to 8·29)§; p=0·46 |
| Respiratory rate per min | 20 (6·5) | 19 (5·6) | .. | 0·59 (−0·79 to 1·97)§; p=0·40 |
| Oxygen saturation | 97 (5%) | 97 (5%) | .. | 0·48 (−0·86 to 1·82)§; p=0·48 |
| Laboratory results (ED arrival) | ||||
| Lactate concentration, mmol/L | 7·04 (4·50) | 6·93 (4·58) | .. | −0·08 (−0·97 to 0·82)§; p=0·87 |
| INR >1·5 | 12/84 (14%) | 12/74 (16%) | 0·91 (0·44 to 1·90)*; p=0·80 | .. |
| Haemoglobin concentration, g/L | 133 (19), 154 | 118 (23), 152 | .. | 15 (10 to 19)‡; p<0·0001 |
| Total blood product up to 24 h after ED arrival | ||||
| PRBC | 6·34 (7·09), 209 | 4·41 (6·17), 223 | .. | 1·80 (0·58 to 3·01)‡; p=0·004 |
| Plasma | 5·04 (5·56), 209 | 3·37 (5·04), 223 | .. | 1·54 (0·57 to 2·50)‡; p=0·002 |
| Death | ||||
| Within 3 h | 32/197 (16%) | 46/208 (22%) | 0·75 (0·50 to 1·13)*; p=0·17 | −7% (−15 to 1)†; p=0·08 |
| Within 30 days | 86/204 (42%) | 99/219 (45%) | 0·94 (0·76 to 1·17)*; p=0·59 | −4% (−13 to 6)†; p=0·44 |
Data are n/N (%); mean (SD); median (IQR) participants, unless otherwise specified. Key secondary outcomes are reported here; all secondary outcomes are reported in the appendix (p 102). IDS=intervention delivery site. INR=International normalised ratio. ED=emergency department. LyoPlas=lyophilised plasma. PRBC=packed red blood cells.
Output is from a log-binomial regression model adjusted for IDS. Values of risk ratio of less than 1 indicate lower event rates in the PRBC–LyoPlas group.
Output is from a binomial regression model with identity link adjusted for IDS. Values of absolute risk difference of less than 0 indicates lower event rates in the PRBC–LyoPlas group.
Output is a from linear regression model adjusted for IDS. Values of mean differences of less than 0 indicate lower average values the PRBC–LyoPlas group.
Output is from a linear regression model adjusted for IDS and the on scene value of the outcome variable. Values of mean differences <0 indicate lower average values in PRBC–LyoPlas group.