IV Solution Treats Surgical Blood Volume Loss

Voluven, a synthetic starch (6% hydroxyethyl starch) solution that does not dissolve in water, is formed by linked individual starch molecules combined with normal saline (0.9% sodium chloride); the starch solution works by expanding blood volume, restoring some of the blood volume lost during surgery. The starch-enriched plasma draws fluid into the capillaries so that remaining red blood cells can continue to deliver oxygen to the body's tissues.

In clinical trials, Voluven was compared to other approved blood volume expanders. In newborns and infants undergoing major surgery, it was found as safe and effective as an equivalent volume of another approved starch solution expander containing albumin, Hespan, manufactured by B. Braun Medical (Bethlehem, PA, USA). In other trials conducted outside of the United States, Voluven was as safe as other blood volume expanders used in those countries in patients ranging in age from less than two years to 75 years who were undergoing a variety of surgical procedures.

Voluven is not recommended for patients with known abnormal sensitivity to the synthetic starch used in the product; patients experiencing fluid overload; patients with kidney failure not related to low blood volume; patients on dialysis; patients with severe increases in blood levels of sodium or chloride; and patients with intracranial bleeding. Voluven is manufactured by Fresenius Kabi (Bad Homburg, Germany), and has been approved by the U.S. Food and Drug Administration (FDA).

"Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups,” said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for biologics evaluation and research.


Related Links:
Fresenius Kabi
B. Braun Medical