Table 2:
Outcomes
| Plasma group (n=65) | Control group (n=60) | Effect size (95% Cl)* | p value | |
|---|---|---|---|---|
| Clinical outcome | ||||
| Mortality at 28 days† | 10 (15%) | 6 (10%) | 1·54 (0·60 to 3·98) | 0·37 |
| Mortality at 24 h | 8 (12%) | 6 (10%) | 1·23 (0·45 to 3·34) | 0·68 |
| Acute lung injury within 28 days | 28 (43%) | 30 (50%) | 0·86 (0·59 to 1·26) | 0·44 |
| Multiple organ failure within 28 days (Denver score >3) | 4 (6%) | 1 (2%) | 3·69 (0·42 to 32·11) | 0·37 |
| Composite outcome (multiple organ failure or death) at 28 days‡ | 14 (21%) | 7 (12%) | 1·85 (0·80 to 4·26) | 0·14 |
| Ventilator-free days | 26 (11 to 28) | 26 (18 to 28) | 0 (−1·00 to 0) | 0·35 |
| Intensive-care-free days | 23 (7 to 26) | 24 (17 to 26) | 0 (−3·00 to 1·00) | 0·49 |
| Physiology and shock | ||||
| SBP on arrival (mm Hg) | 96 (80 to 110) | 90 (72 to 111) | 5·00 (−6·00 to 15·00) | 0·38 |
| Heart rate on arrival (bpm) | 105 (76 to 124) | 111 (92 to 128) | −6·00 (−17·00 to 4·00) | 0·23 |
| Haemoglobin concentration on arrival (g/dL) |
12·6 (11·3 to 14·7) | 13·5 (11·9 to 14·7) | −0·30 (−1·10 to 0·50) | 0·50 |
| Lowest haemoglobin concentration in 1–6 h (g/dL) | 11·3 (9·6 to 12·6) | 11·0 (9·1 to 12·8) | 0·20 (−0·70 to 1·00) | 0·67 |
| Haemoglobin concentration <70 g/L in 1–6 h | 3 (5%) | 2 (3%) | 0·41 (0·24 to 8·13) | 1·00 |
| Base deficit on arrival (mEq/L)‡ | 9·0 (5·5 to 13·0) | 8·8 (6·0 to 13·0) | 0 (−2·70 to 2·00) | 0·80 |
| Base deficit >10 mEq/L | 21/51 (41%) | 22/50 (44%) | 0·94 (0·59–1·47) | 0·77 |
| Lactic acid concentration on arrival (mg/dL)‡ | 5·5 (3·9 to 8·5) | 4·9 (3·2 to 7·0) | 0·60 (−0·60 to 1·80) | 0·30 |
| Coagulation (on arrival at hospital) | ||||
| INRon arriva† | 1·27 (1·11 to 1·40) | 1·15 (1·08 to 1·29) | 0·60 (−001 to 0·14) | 0·10 |
| INR>1·3 | 28/63 (44%) | 14/58 (24%) | 1·84 (1·08 to 3·14) | 0·02 |
| Rapid thromboelastography | ||||
| G (dynes/cm2)‡ | 7·7 (6·2 to 8·9) | 7·1 (5·4 to 9·7) | 0·30 (−0·90 to 1·40) | 0·66 |
| Activated clotting time (s) | 128 (113 to 136) | 121 (113 to 136) | 0 (−7·00 to 8·00) | 0·76 |
| Maximum amplitude (mm) | 60·5 (55·5 to 64·0) | 58·5 (52·0 to 66·0) | 100 (−2·50 to 4·50) | 0·67 |
| Angle (°) | 70·9 (66·1 to 76·1) | 69·3 (63·2 to 74·4) | 2·20 (−0·80 to 5·40) | 0·16 |
| LY30(%) | 1·3 (0·3 to 2·6) | 1·6 (0·7 to 3·1) | −0·20 (−0·90 to 0·30) | 0·32 |
| Hyperfibrinolysis (LY30 >3·0%) | 14/56 (23%) | 13/51 (25%) | 0·91 (0·47 to 1·78) | 0·78 |
| Physiological lysis (LY30 0·9–3·0%) | 25/56 (45%) | 23/51 (45%) | 0·99 (0·65 to 1·51) | 0·96 |
| Lysis shutdown (LY30 <0·9%) | 18/56 (32%) | 15/51 (29%) | 1·09 (0·62 to 1·93) | 0·76 |
| Coagulation factor on arrival at hospital(% activity) | ||||
| Fibrinogen on arrival (mg/dL) | 195·0 (157·0 to 275·0) | 222·0 (154·5 to 282·0) | −10·00 (−30·00 to 48·00) | 0·68 |
| II | 71·0 (57·0 to 88·0) | 79·0 (65·0 to 92·0) | −6·00 (−15·00 to 3·00) | 0·14 |
| V | 64·0 (41·0 to 83·0) | 69·0 (52·0 to 91·0) | −7·00 (−20·00 to 5·00 | 0·32 |
| VII | 72·0 (56·0 to 94·0) | 74·0 (52·0 to 94·0) | 3·00 (−8·00 to 13·00) | 0·61 |
| VIII | 283·4 (168·4 to 434·2) | 355·2 (279·0 to 462·6) | −71·70 (−148·00 to 2·00) | 0·06 |
| IX | 121·0 (87·0 to 142·0) | 135·0 (99·0 to 159·0) | −11·00 (−30·00 to 2·00 | 0·36 |
| XI | 81·0 (58·0 to 127·0) | 109·0 (72·0 to 135·0) | −14·00 (−35·00 to 8·00) | 0·21 |
| XIII§ | 0/47 | 2/41 (5%) | 0·18 (0·01 to 3·54) | 0·21 |
| Transfusions or fluids after injury | ||||
| Red blood cell units per 24 h | 2·0 (0 to 9·0) | 1·5 (0 to 9·0) | 0 (−1·0 to 0) | 0·89 |
| Red blood cell units needed within 24 h | 36 (55%) | 35 (58%) | 0·95 (0·70 to 1·29) | 0·74 |
| Massive transfusion (>10 units red blood cells) or death within 6 h | 15 (23%) | 12 (20%) | 115 (0·59 to 2·26) | 0·68 |
| Time from injury to first red blood cell unit (mm)‡ | 46·5 (32·0 to 55·5) | 37·0 (24·0 to 46·0) | 8·00 (0 to 16·00) | 0·05 |
| Time from emergency admission to first red blood cell unit (min)‡ | 16 (7 to 28) | 10 (4 to 18) | 5·0 (0 to 11·0) | 0·05 |
| Plasma units needed per 24 h|| | 0 (0 to 4·0) | 0 (0 to 3·0) | 0 (0 to 0) | 0·98 |
| Plasma needed within 24 h¶ | 29 (45%) | 26 (43%) | 1·03 (0·69 to 1·53) | 0·88 |
| Platelet units per 24 h | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0·31 |
| Platelets needed within 24 h | 15 (23%) | 11 (18%) | 1·26 (0·63 to 2·52) | 0·51 |
| Cryoprecipitate units per 24 h | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0·30 |
| Cryoprecipitate needed within 24 h | 8 (12%) | 4 (7%) | 1·85 (0·59 to 5·82) | 0·28 |
| Tranexamicacid needed within 6 h | 6 (9%) | 8 (13%) | 0·69 (0·26 to 1·88) | 0·47 |
| Factor VII per needed within 24 h | 1(2%) | 0 | 0·69 (0·30 to 1·56) | 1·00 |
| Normal saline in used the field (mL) | 150 (0 to 300) | 250 (100 to 500) | −100 (−200 to 0) | 0·02 |
Data are median (IQR) or n (%). Significance was set at p<0∙0379 in the final analyss, per the O’Brien-Fleming spending function, to maintain overall study significance at p<0∙05. SBP=systolic blood pressure. INR=international normalised ratio. LY30=percentage lysis 30 min after maximum amplitude. bpm=beats per minute.
*
For cells with 0 values, the relative risk was estimated by adding 0∙5 to each cell.
†
Primary endpoint.
‡
Secondary endpoint.
§
Measured with a qualitative assay.
¶
Excludes plasma given in field.