(Ivanhoe Newswire) -- Hemoglobin-based blood substitutes (HBBSs), or
artificial blood, may put patients at risk for heart attack or even death, a new
study reveals.
The development of blood substitutes may help save the lives of surgical and
trauma patients in shock from blood loss and could be especially useful for
rural or military areas. The liquids have a long shelf-life without requiring
refrigeration and they don’t cause infection; but a recent analysis of 16
randomized controlled trials shows a dangerous association between these
products and surgical, trauma and stroke patients. The trials revealed patients
who received HBBSs had a 30 percent increased risk of death and 2.7 times
increased risk of heart attack.
“To date, a large proportion of blood substitutes in development have been
hemoglobin-based products [hemoglobin is the oxygen-carrying protein in the red
blood cells],” study authors write. “Yet randomized controlled trials completed
as early as 1996 have raised questions about the safety of these products and
have failed to demonstrate clinical benefit.”
After trials are completed, study sponsors must report their results to the U.S.
Food and Drug Administration (FDA), but researchers say the FDA only makes data
available to the public if the product is approved or if an advisory committee
is assembled to discuss the product. “The cumulative mortality analysis …
indicates that prompt meta-analyses of the HBBS trials by the FDA most likely
would have demonstrated significant risks by 2000. Had the agency placed a
moratorium on trials at that point, product-related deaths and [heart attacks]
in subsequent trials most likely would have been prevented. However, such data
were not available to scientists, the public, institutional review boards, or
competing HBBS manufacturers,” the authors write.
SOURCE: The Journal of the American Medical Association, 2008;299
