Table 4.
Day 30 mortality by subgroups
| Characteristic | As Randomized (N =714)
|
As Treated (N = 14)
|
Per Protocol (N =590)
|
Major Protocol Violations (N = 124)
|
||||
|---|---|---|---|---|---|---|---|---|
| PolyHeme (N = 350) | Control (N = 364) | PolyHeme (N = 349) | Control (N = 365) | PolyHeme (N = 279) | Control (N = 311) | PolyHeme (N = 71) | Control (N = 53) | |
| Mortality by mechanism of injurya | ||||||||
|
| ||||||||
| Blunt | 30/166 (18.1)d | 18/174 (10.3) | 30/165 (18.2)d | 18/175 (10.3) | 22/138 (15.9) | 17/154 (11.0) | 8/28 (28.6) | 1/20 (5.0) |
|
| ||||||||
| Penetrating | 17/184 (9.2) | 17/186 (9.1) | 16/183 (8.7) | 18/187 (9.6) | 9/141 (6.4) | 12/156 (7.7) | 8/43 (18.6) | 5/30 (16.7) |
|
| ||||||||
| Mortality by ISS categorya,b | ||||||||
|
| ||||||||
| Mild/moderate (1–8) | 1/56 (1.8) | 1/60 (1.7) | 0/51 (0) | 2/65 (3.1) | 0/47 (0) | 0/53 (0) | 1/9 (11.1) | 1/7 (14.3) |
|
| ||||||||
| Serious (9–15) | 4/107 (3.7) | 2/101 (2.0) | 4/107 (3.7) | 2/101 (2.0) | 3/87 (3.4) | 2/90 (2.2) | 1/20 (5.0) | 0/11 (0) |
|
| ||||||||
| Severe (16–24) | 8/61 (13.1) | 5/74 (6.8) | 8/60 (13.3) | 5/75 (6.7) | 6/51 (11.8) | 4/67 (6.0) | 2/10 (20.0) | 1/7 (14.3) |
|
| ||||||||
| Critical (25–75) | 34/126 (27.0) | 25/123 (20.3) | 33/129 (25.6) | 26/120 (21.7) | 22/94 (23.4) | 22/99 (22.2) | 12/32 (37.5) | 3/24 (12.5) |
|
| ||||||||
| Mortality regression model interaction termsc | ||||||||
|
| ||||||||
| By randomization SBP | 0.687 | 0.751 | 0.919 | ND | ||||
|
| ||||||||
| By APACHE age category | 0.333 | 0.236 | 0.462 | ND | ||||
|
| ||||||||
| By mechanism of injury | 0.187 | 0.146 | 0.350 | ND | ||||
|
| ||||||||
| By ISS | 0.981 | 0.645 | 0.863 | ND | ||||
|
| ||||||||
| By GCS | 0.536 | 0.703 | 0.172 | ND | ||||
|
| ||||||||
| By prerandomization crystalloid | 0.194 | 0.106 | 0.101 | ND | ||||
|
| ||||||||
| By sex | 0.312 | 0.914 | 0.779 | ND | ||||
Abbreviation: ND, Not determined.
a
Values are expressed as number of deaths (%).
b
Six patients did not have an ISS calculated: four were patients who had non-trauma-related blood loss; two were trauma patients who died early post injury and had inadequate documentation of their injuries.
c
P values.
d
P<.05 compared with Control.
Data from Moore EE, Moore FA, Fabian TC, et al. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA Multicenter Trial. J Am Coll Surg 2009;208:1–13.