Controlled safety study of a hemoglobin-based oxygen carrier, DCLHb, in acute ischemic stroke

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Abstract

Background and Purpose - Diaspirin cross-linked hemoglobin (DCLHb) is a purified, cell-free human hemoglobin solution. In animal stroke models its use led to a significant reduction in the extent of brain injury. The primary objective of this study was to evaluate the safety of DCLHb in patients with acute ischemic stroke. Methods - DCLHb or saline was administered to 85 patients with acute ischemic stroke in the anterior circulation, within 18 hours of onset of symptoms, in a multicenter, randomized, single-blind, dose- finding, controlled safety trial, consisting of 3 parts: 12 doses of 25, 50, and 100 mg/kg DCLHb over 72 hours. Results - DCLHb caused a rapid rise in mean arterial blood pressure. The pressor effect was not accompanied by complications or excessive need for antihypertensive treatment. Two patients in the 100 mg/kg group had adverse events that were possibly drug related: one suffered fatal brain and pulmonary edema, the other transient renal and pancreatic insufficiency. Multivariate logistic regression analysis showed that a severe stroke at baseline and treatment with DCLHb (OR, 4.0; CI, 1.4 to 12.0) were independent predictors of a worse outcome (Rankin Scale Score of 3 to 6) at 3 months. Conclusions - Outcome scale scores were worse in the DCLHb group, and more serious adverse events and deaths occurred in DCLHb- treated patients than in control patients. We recommend that additional safety studies be performed, preferably with a second generation, genetically engineered hemoglobin.

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Saxena, R., Wijnhoud, A. D., Carton, H., Hacke, W., Kaste, M., Przybelski, R. J., … Koudstaal, P. J. (1999). Controlled safety study of a hemoglobin-based oxygen carrier, DCLHb, in acute ischemic stroke. Stroke, 30(5), 993–996. https://doi.org/10.1161/01.STR.30.5.993

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