Lack of Consistent Diaspirin Cross-Linked Hemoglobin Infusion Blood Pressure Effects in the US and EU Traumatic Hemorrhagic Shock Clinical Trials

摘要

Hemoglobin solutions have demonstrated a pressor effect that could adversely affect hemorrhagic shock patient resuscitation through accelerated hemorrhage, diminished perfusion, or inadequate resuscitation. Data from two parallel, multicenter traumatic hemorrhagic shock clinical trials in 17 US emergency departments and in 27 EU prehospital systems using diaspirin cross- linked hemoglobin (DCLHb), a hemoglobin-based resuscitation fluid. In the 219 patients, patients were 37 years old, 64% sustained blunt injury, 48% received DCLHb, and 36% expired. Although mean systolic blood pressure (SBP) and diastolic blood pressure values differed at 2 of the 10 measured time points, blood pressure (BP) curve analysis showed no SBP, diastolic blood pressure, or MAP differences based on treatment. Although SBP values 160 and 120 mmHg or greater were 2.2x and 2.6x more frequently noted in survivors, they were not more common with DCLHb use or in DCLHb patients who expired in US study nonsurvivors or in any EU study patients. Systolic blood pressure values 160 and 120 mmHg or greater were 2.8x and 1.3x more frequently noted in DCLHb survivors as compared with normal saline survivors. Only 3% of the BP variation noted could be attributed to DCLHb use, and as expected, injury severity and baseline physiologic status were stronger predictors. In the United States alone, treatment group was not correlated by regression with BP at any time point. Neither mean BP readings nor elevated BP readings were correlated with DCLHb treatment of traumatic hemorrihagic shock patients. As such, no clinically demonstrable DCLHb pressor effect could be directly related to the adverse mortality outcome observed in the US study.