Table 5.
Investigator-reported adverse events
| Event | As Treated (N = 714) | |
|---|---|---|
| PolyHeme (N = 349) | Control (N = 365) | |
| AEs | 324 (93)b | 322 (88) |
| SAEs | 141 (40) | 126 (35) |
| Most common SAEs (>2%) | ||
| Pneumonia | 27 (8) | 21 (6) |
| Hemorrhagic shock | 20 (6) | 16 (4) |
| Respiratory failure | 21 (6) | 17 (5) |
| Hypercoagulable state | 18 (5) | 12 (3) |
| Coagulopathy | 13 (4)b | 4 (1) |
| Sepsis | 12 (3) | 11 (3) |
| MI | 10 (3)b | 2 (1) |
| MI AEsa | 11 (3)b | 3 (1) |
| MI | 7 | 2 |
| NSTEMI | 3 | 0 |
| Non–Q wave MI | 0 | 1 |
| Acute traumatic MI | 1 | 0 |
| Requiring intervention | 1 | 1 |
| Death within 30 d | 3 | 1 |
| Cardiovascular events | ||
| Heart failure/CHF/PE/fluid overload/hypervolemia | 20 (6) | 20 (5) |
| Cardiac arrest/EMD/VFib/V-arrhythmia/VT | 15 (4) | 9 (2) |
| CVA/cerebral ischemia/cerebral infarction | 3 (1) | 1 (1) |
| MOF in 30 d (adjudicated) | 26 (7) | 20 (6) |
| Renal (creatinine >1.8 mg/dL) | 13/26 (50) | 9/20 (45) |
| Hepatic (total bilirubin >2.0 mg/dL) | 20/26 (77) | 15/20 (75) |
| Cardiac (inotropes) | 9/26 (35) | 4/20 (20) |
| Pulmonary (PaO2/FIO2 <240) | 24/26 (92) | 19/20(95) |
Values are expressed as n (%): the number of patients who had the event divided by the total number of patients in each treatment group.
Abbreviations: CHF, Congestive heart failure; CVA, Cerebrovascular accident; EMD, Electro-mechanical dissociation; FIO2, Fraction of inspired oxygen; MI, Myocardial infarction; NSTEMI, Non–ST-segment MI; PE, Pulmonary embolism; V, Ventricular; VFib, Ventricular fibrillation; VT, Ventricular tachycardia.
Two MI events were not considered “serious” by the investigator.
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.