Table 1. Baseline Demographics and Clinical Characteristics by Treatment Group.
Factor | Study Group | ASDa | |||
---|---|---|---|---|---|
AVP Supplementation (n = 49) | Placebo (n = 51) | ||||
No. Missing | Data | No. Missing | Data | ||
Patient demographics | |||||
Age, median (IQR), y | 0 | 26 (21-31) | 0 | 27 (24-36) | 0.35 |
Male, No. (%) | 0 | 46 (94) | 0 | 47 (92) | 0.07 |
Race/ethnicity, No. (%) | |||||
Black | 0 | 42 (86) | 0 | 40 (78) | 0.36 |
White | 0 | 7 (14) | 0 | 8 (16) | |
Hispanic | 0 | 0 | 0 | 2 (4) | |
Asian | 0 | 0 | 0 | 1 (2) | |
Injury characteristics | |||||
Penetrating mechanism, No. (%) | 0 | 39 (80) | 0 | 40 (78) | 0.03 |
Injury Severity Score, median (IQR)b | 0 | 19 (14-26) | 0 | 26 (17-34) | 0.29 |
PATI, median (IQR)c | 0 | 32 (27-44) | 0 | 26 (16-40) | 0.38 |
Primary source of hemorrhage, No. (%) | |||||
Head | 0 | 0 | 0 | 1 (2) | 0.31 |
Neck | 0 | 2 (4) | 0 | 3 (6) | |
Thoracic | 0 | 14 (29) | 0 | 12 (24) | |
Abdominal | 0 | 21 (43) | 0 | 26 (51) | |
Extremity | 0 | 12 (24) | 0 | 9 (18) | |
Hemorrhage control, No. (%) | |||||
Operating room | 0 | 48 (98) | 0 | 50 (98) | 0.29 |
Interventional radiology | 0 | 0 | 0 | 1 (2) | |
Both | 0 | 1 (2) | 0 | 0 | |
AIS ≥4, No. (%) | |||||
Neck | 0 | 5 (10) | 0 | 1 (2) | 0.35 |
Chest | 0 | 17 (35) | 0 | 16 (31) | 0.07 |
Abdomen | 0 | 20 (41) | 0 | 16 (31) | 0.19 |
Extremity | 0 | 5 (10) | 0 | 5 (10) | 0.01 |
Trauma bay admission vital signs, mean (SD) | |||||
SBP, mm Hg | 0 | 113 (29) | 0 | 114 (35) | 0.02 |
MAP, mm Hg | 1 | 76 (24) | 0 | 82 (33) | 0.20 |
HR, bpm | 0 | 105 (27) | 0 | 109 (26) | 0.15 |
Glasgow Coma Score, median (IQR)d | 0 | 14 (10-15) | 0 | 14 (8-15) | 0.17 |
Time to enrollment, median (IQR), min | 0 | 97 (69-122) | 0 | 80 (56-102) | 0.29 |
Enrollment vital signs | |||||
Lowest SBP, mean (SD), mm Hg | 0 | 77 (21) | 0 | 69 (20) | 0.38 |
SBP, mean (SD), mm Hg | 0 | 99 (31) | 0 | 90 (29) | 0.30 |
MAP, mean (SD), mm Hg | 0 | 70 (19) | 0 | 66 (21) | 0.18 |
HR, mean (SD), bpm | 0 | 103 (17) | 0 | 106 (25) | 0.14 |
Temperature, median (IQR), °C | 5 | 36 (35-37) | 5 | 36 (35-36) | 0.33 |
Trauma evaluation laboratory values | |||||
Lactate level, median (IQR), mg/dL | 9 | 6 (4-9) | 11 | 7 (5-11) | 0.35 |
Sodium level, mean (SD), mEq/L | 4 | 139 (3) | 8 | 140 (4) | 0.26 |
Creatinine level, mean (SD), mg/dL | 5 | 1.35 (0.25) | 8 | 1.33 (0.25) | 0.03 |
Hemoglobin level, mean (SD), g/dL | 4 | 12.6 (1.7) | 8 | 12.0 (1.9) | 0.33 |
Platelet count, mean (SD), ×103/μL | 5 | 226 (74) | 8 | 222 (77) | 0.06 |
Prothrombin time, INR, median (IQR) | 5 | 1.2 (1.1-1.4) | 9 | 1.2 (1.2-1.4) | 0.22 |
Partial thromboplastin time, median (IQR), s | 5 | 27 (25-32) | 9 | 29 (26-35) | 0.11 |
Preenrollment resuscitation requirements | |||||
Crystalloids, median (IQR), L | 0 | 2.1 (1.5-3.6) | 0 | 2.0 (1.1-2.8) | 0.32 |
Blood products, median (IQR), L | 0 | 1.8 (1.8-2.3) | 0 | 2.0 (1.8-2.2) | 0.07 |
PRBC, median (IQR), L | 0 | 1.5 (1.2-1.8) | 0 | 1.5 (1.5-1.8) | 0.08 |
FFP, median (IQR), L | 0 | 0.5 (0.3-0.5) | 0 | 0.5 (0.1-0.5) | 0.18 |
Platelets, median (IQR), mL | 0 | 0 (0-0) | 0 | 0 (0-0) | 0.14 |
Cryoprecipitate, median (IQR), mL | 0 | 0 (0-0) | 0 | 0 (0-0) | <0.001 |
Estimated blood loss, median (IQR), mL | 0 | 250 (0-800) | 1 | 25 (0-675) | 0.15 |
Factor VII, No. (%) | 0 | 0 | 0 | 0 | <0.001 |
Tranexamic acid, No. (%) | 0 | 18 (37) | 0 | 23 (45) | 0.17 |
Abbreviations: AIS, Abbreviated Injury Score; ASD, absolute standardized difference; bpm, beats per minute; AVP, arginine vasopressin; FFP, fresh frozen plasma; HR, heart rate; INR, international normalized ratio; IQR, interquartile range; MAP, mean arterial pressure; PATI, Penetrating Abdominal Trauma Index; PRBC, packed red blood cells; SBP, systolic blood pressure.
SI conversion factors: To convert creatinine to micromoles per liter, multiply by 88.4; hemoglobin to grams per liter, multiply by 10.0; lactate to millimoles per liter, multiply by 0.111; platelets to 109 per liter, multiply by 1.0; sodium to millimoles per liter, multiply by 1.0.
Defined as the absolute difference in means, mean ranks, or proportions between groups divided by the pooled SD. Variables with ASD of greater than 0.392 are defined as imbalanced between groups. An ASD of no greater than 0.392 will capture 95% of the participants if the true ASD is zero for that variable.
Scores range from 0 to 75, with higher scores indicating more severe injury.
Applicable only for patients with an abdominal injury; summary includes 25 in the AVP group and 23 in the placebo group. Scores range from 0 to 200, with higher scores indicating greater severity.
Scores range from 3 to 15, with higher scores indicating greater level of consciousness.