Nonconsent saline study held until January
Trauma trial delayed while coordinators sync procedures
A clinical study that potentially could include any resident of four Portland-area counties is set to begin in January after a November delay.
The study, to be conducted by Oregon Health and Science University in Multnomah, Washington and Clackamas counties as well as Clark County, Wash., will test one of two intravenously administered solutions on severe trauma patients brought to hospitals by ambulance. Most of those patients will be victims of automobile accidents.
The trial is unusual in that it seeks to investigate differing therapies on subjects who have not given their consent. The normal informed-consent procedure is impossible to conduct on trauma patients, who need immediate attention and who often are unconscious. But physicians need data on which therapies work best on just such emergency patients.
The delay, according to OHSU spokeswoman Liana Haywood, was so study coordinators could standardize monitoring procedures in each of the 11 participating national sites.
Some concern was expressed over elevated sodium levels in study participants in areas where the trial already had begun. (The solutions being tested have a higher saline level than the traditional solution given to trauma victims.)
Haywood said the new rules increase the number of times hospitals will check sodium levels in patients who are part of the study.
Area residents who would not wish to be part of the study can opt out by contacting OHSU and requesting a metal bracelet inscribed 'No Study.'