Diaspirin cross-linked hemoglobin infusion did not influence base deficit and lactic acid levels in two clinical trials of traumatic hemorrhagic shock patient resuscitation.

BACKGROUND: Diaspirin cross-linked hemoglobin (DCLHb) has demonstrated a pressor effect that could adversely affect traumatic hemorrhagic shock patients through diminished perfusion to vital organs, causing base deficit (BD) and lactate abnormalities. METHODS: Data from two parallel, multicenter traumatic hemorrhagic shock clinical trials from 17 US Emergency Departments and 27 European Union prehospital services using DCLHb, a hemoglobin-based resuscitation fluid. RESULTS: In the 219 patients, the mean age was 37.3 years, 64% of the patients sustained a blunt injury, 48% received DCLHb resuscitation, and the overall 28-day mortality rate was 36.5%. BD data did not differ by treatment group (DCLHb vs. normal saline [NS]) at any time point. Study entry BD was higher in patients who died when compared with survivors in both studies (US: -14.7 vs. -9.3 and European Union: -11.1 vs. -4.1 mEq/L, p < 0.003) and at the first three time points after resuscitation. No differences in BD based on treatment group were observed in either those who survived or those who died from the hemorrhagic shock. US lactate data did not differ by treatment group (DCLHb vs. NS) at any time point. Study entry lactates were higher in US patients who ultimately died when compared with survivors (82.4 vs. 56.1 mmol/L, p < 0.003) and at all five postresuscitation time points. No lactate differences were observed between DCLHb and NS survivors or in those who died based on treatment group. CONCLUSIONS: Although patients who died had more greatly altered perfusion than those who survived, DCLHb treatment of traumatic hemorrhagic shock patients was not associated with BD or lactate abnormalities that would indicate poor perfusion.

The lack of consistent diaspirin cross-linked hemoglobin infusion blood pressure effects in the US and EU traumatic hemorrhagic shock clinical trials.

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 hemorrhagic shock patients. As such, no clinically demonstrable DCLHb pressor effect could be directly related to the adverse mortality outcome observed in the US study.