Table 7.
Independent Data Safety Monitoring Cardiac Sub committee Assignation of Myocardial infarction
| Cardiac Committee Determination | As Treated (n = 714)
|
|||
|---|---|---|---|---|
| PolyHeme (n = 349)
|
Control (n = 365)
|
|||
| n | % | n | % | |
| Chest AIS ≤ 2 | ||||
|
| ||||
| Probable infarction | 19 | 5.4 | 11 | 3.0 |
|
| ||||
| Physiologic stress or possible infarction | 58 | 16.6 | 67 | 18.4 |
|
| ||||
| Possible infarction | 5 | 1.4 | 6 | 1.6 |
|
| ||||
| Total possible or probable infarction | 82 | 23.4 | 84 | 23.0 |
|
| ||||
| Absent infarction | 61 | 17.5 | 52 | 14.2 |
|
| ||||
| Indetermine infarction | 49 | 14.0 | 79 | 21.6 |
|
| ||||
| Chest AIS > 2 | ||||
|
| ||||
| Probable infarction or injury | 23 | 6.6 | 19 | 5.2 |
|
| ||||
| Physiologic stress or possible infarction or injury | 81 | 23.2 | 80 | 21.9 |
|
| ||||
| Possible infarction or injury | 1 | 0.3 | 6 | 1.6 |
|
| ||||
| Total possible or probable infarction or injury | 105 | 30.1 | 105 | 28.8 |
|
| ||||
| Absent infarction or injury | 22 | 6.3 | 12 | 3.3 |
|
| ||||
| Indetermine infarction or injury | 30 | 8.6 | 33 | 9.0 |
Values expressed as n (%); percentages are based on the number of patients in each treatment group divided by number of patients who had nonmissing values.
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.