Vascular Disease Clinical Trial
Official title:
A Phase II Study of Hemospan® Versus Voluven® to Evaluate Vascular Resistance and Forearm Blood Flow, and to Assess Local Skin Blood Flow and Tissue Oxygenation in the Ischemic Foot of Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.
Hemospan® is a novel hemoglobin-based oxygen carrier developed to perfuse and oxygenate
tissue at risk for ischemia and hypoxia. Because of its molecular size and oxygen binding
characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen
tension. Preclinical evidence suggests that Hemospan provides volume expansion and enhances
tissue perfusion. Hemospan is therefore being developed as an oxygen-carrying plasma
expander for patients where tissues are at risk of inadequate perfusion and oxygenation.
In patients with chronic critical lower limb ischemia (CCLI), the primary cause of ischemic
symptoms in the leg is insufficient perfusion. As many of the patients suffering from CCLI
are elderly and have concomitant disease, surgical procedures may not always be possible.
The goal of all treatments is to improve the blood flow in the nutritional vessels of the
ischemic areas; one such possibility may be to use an oxygen-carrying plasma expander.
Hemospan has been shown to improve the oxygenation of tissues by preserving functional
capillary density. In addition, Hemospan has a high affinity for oxygen - a feature that is
specifically designed to target the unloading of oxygen in the microcirculation where local
PO2 levels are much lower (e.g., in ischemic regions). Since Hemospan is a cell-free oxygen
carrier, it should be able to perfuse capillaries that are so constricted that red blood
cells are unable to flow through them.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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