A University of Cincinnati study has demonstrated the importance of enrolling subjects by surrogate consent in a pioneering stroke trial that was undertaken between 1991 and 1994.
This significant research was published in the November 11 issue of the American Academy of Neurology’s medical journal, Neurology.
The early 1990s trial in question lead the US Food and Drug Administration to approve rt-PA (recombinant tissue plasminogen activator), the only officially sanctioned treatment for ischemic
stroke patients on the market.
Those who suffer from blood clot induced ischemic stroke are often unable to make well informed decisions due to subsequently impaired cognitive functions. This often necessitates the presence of a surrogate who can act on the victim’s behalf.
The UC study indicates that the rt-PA trial, which took just under four years to complete, would have plodded along for up to 12.5 years, had 70% of the trial’s subjects not been enrolled via surrogate consent.
This is a good thing for stroke victims, annually numbering approximately 10,800 to 12,600 in the US, as they now have access to this potentially life-saving treatment, thanks in part to this early 1990s trial.
Next on the agenda, the UC study concludes that the revision of outdated state laws regarding surrogate selection criteria is necessary to continue advancing this important work.
The UC study was lead by Matthew Flaherty, MD, an assistant professor in UC’s department of neurology, in collaboration with colleagues from the University of Pennsylvania and the Center for
Epidemiology and Biostatistics at Cincinnati Children’s Hospital Medical Center.
More information on this study can be found here.
Writer: Jonathan DeHart
Source: University of Cincinnati
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