OHSU study on emergency trauma patients is delayed
National oversight board puts off trial after report of a complication in another city
A national medical trial scheduled to begin in the Portland area Wednesday has been delayed after a national oversight board received a report from an already-participating city of a hospitalized patient with an elevated blood sodium level.
Oregon Health and Science University's hypertonic saline trial will target Multnomah, Washington, Clackamas and Clark county residents who suffer severe trauma and are transported to hospitals by ambulance. The study is intended to determine whether a new intravenously administered saline solution can improve survival rates over a traditional saline solution.
Researchers anticipate most study participants will be victims of automobile accidents.
The trial is the second conducted locally under federal guidelines that allow researchers to disregard conventional informed consent rules. Area residents who do not wish to participate in the trial must be wearing special 'No Study' bracelets supplied by Oregon Health and Science University at the time they are attended to by paramedics.
Gary Oxman, health officer for Multnomah County and reviewer of the study for the local Institutional Review Board, which must give consent for the study to take place, said Wednesday that the elevated sodium level discovered in 'one or two patients' was not expected to pose a health risk
to participants. Oxman said the study's designers would be taking a look at increasing protocols for measuring blood sodium levels in participants before starting up the trial again. All 11 national sites have halted the study.
'Researchers will tend to report adverse effects fairly freely,' Oxman said.
An OHSU spokesperson said they did not know when the study would begin.
If you do not want to participate in the saline study, you may call OSHU To obtain a bracelet that says "no study" by calling OHSU study coordinator Denise Griffiths at 503 494-7015. More information about the study can be found at www.ohsu.edu/emergency/roc/