A prospective trial of diaspirin cross-linked hemoglobin solution in patients after elective repair of abdominal aortic aneurysm.

We evaluated the safety, pharmacokinetics, and pharmacodynamics of diaspirin cross-linked hemoglobin (DCLHb) solution in patients after repair of abdominal aortic aneurysm. We performed a randomized, single-blind controlled study with 10 patients in the surgical intensive care unit of a tertiary care facility. Within 24 hours after repair of an abdominal aortic aneurysm, each patient received an infusion of DCLHb (50 mg/kg or 35 mL for a 70-kg patient) or an equal volume of hetastarch. Variables were measured before infusion, at 15 and 30 minutes postinfusion, and at hourly intervals up to 72 hours. Compared with controls, the experimental group had significantly greater mean pulmonary artery pressure at 30 minutes (mean +/- SD, 26.4 +/- 3.18 vs. 22.8 +/- 2.86 mm Hg), greater mean arterial pressure through 30 minutes (100.8 +/- 8.67 vs. 81.6 +/- 13.8 mm Hg), and greater plasma hemoglobin through 2 hours (69.3 +/- 6.08 vs. 1.8 +/- 0 g/dL). Cardiac output was significantly less in the DCLHb group at 2 hours (5.34 +/- 7.92 vs. 6.18 +/- 0.54 L/minute), levels of serum bilirubin were significantly less at 24 and 48 hours (94 +/- 0.26 vs. 1.56 +/- 0.73 mg/dL), and platelet counts were significantly greater at 24 hours (128 +/- 35.8 vs. 101 +/- 55.7 mg/dL). The two groups did not differ in oxygen delivery or consumption. One patient treated with DCLHb had a myocardial infarction 36 hours postinfusion. No patient had antibodies to DCLHb. At this dosage, DCLHb was well tolerated without severe organ dysfunction or toxicity. However, its use may lead to decreases in cardiac output because of increases in afterload, which may pose serious problems with left ventricular function.

RCT Entities:   Population Interventions Outcomes