Copyright 2006 The Oregonian
All Rights Reserved
By ANDY DWORKIN
The Oregonian (Portland, Oregon)
For the second time in two years, Portland-area doctors want to study a medical treatment on trauma victims too sick to agree to the experiment.
The trial would compare the normal saline solution emergency medical crews give badly injured patients with two solutions that contain more sodium. Blood is too perishable for ambulances to carry. So medics at trauma scenes give saline to people who have lost blood, helping push fluid and oxygen to organs until patients reach a hospital.
Even with saline treatment, trauma kills more than 100,000 U.S. residents a year. Some scientists think concentrated, or hypertonic, saline will help more people survive head injuries or severe blood loss. The saltier solution may limit brain swelling and a life-threatening kind of inflammation that can shut down organs days after a trauma. Small studies have not found bad side effects, but possible problems include dangerously high sodium levels or allergies to one of the test solutions, which contains a sugary substance.
Portland is one of 11 U.S. and Canadian cities wanting to test the hypertonic saline as part of the Resuscitation Outcomes Consortium. The group has $50 million from the governments and nonprofit heart associations in the United States and Canada to do several studies. The saline trial could start this summer and run three years.
Such trauma experiments present one big problem: The injured are usually unconscious, in shock or otherwise hurt so badly that they can not fully understand or agree to a medical trial. Ethics and laws usually require getting informed consent from someone to experiment on them.
A 1996 federal regulation, controversial among ethicists, allows emergency medicine tests without consent if a treatment is likely to help people with life-threatening injuries and if current treatments are unsatisfactory. In such cases, researchers have to teach community members about their plans and address their concerns and questions in advance.
Community members don’t all have to agree for a trial to go forward. But their reaction is weighed by Institutional Review Boards, which ensure medical studies are ethical and well-designed.
Starting tonight, researchers will hold a public meeting in each of the Portland-metro counties where emergency medical services might use the concentrated saline: Clackamas, Clark, Multnomah and Washington.
“We want to make sure the community has a chance to voice any concerns about the study, while at the same time being informed about the study,” said Dr. Mohamud Daya, one of the Oregon Health & Science University trauma experts leading Portland’s part of the trial.
The saline study would include trauma victims with serious brain injuries or shock from lost blood. Pregnant women, children younger than 15 and people under arrest would be excluded. Portland-area medics might enroll 50 to 100 people a year for blood loss, and three to four times that number for head trauma, Daya said.
The saline study is the third to try the federal consent waiver in Portland. The first was Public Access to Defibrillation trial, which ended in 2003. That 24-city trial showed that having defibrillators and trained users in public places, such as malls, doubles the chance that someone will survive a cardiac arrest.
Doctors at OHSU and Legacy Health Systems also had hoped to test a blood substitute, called PolyHeme, on trauma victims. But after two years of work, they dropped their bid to join the trial in December.
Ethical questions and limited community input delayed Portland researchers until it was too late to join the PolyHeme test. Four 2005 community meetings on PolyHeme drew about 75 people and only 31 formal comments. The hospitals backed off initial plans to do more education, including efforts to target minority groups, which limited comment.
The review board for Oregon and Multnomah County’s public health agencies also had ethical “concerns” about the PolyHeme trial, said Dr. Gary Oxman, Multnomah County health officer and review board member. Some worried that the blood substitute could be given in a hospital, when real blood was available. And they were uneasy about bad reactions in earlier PolyHeme trials. The company that makes PolyHeme, and sponsored the trial, has since said 10 users suffered heart attacks in an earlier study.
“PolyHeme was sort of an eye-opener for a lot of people here,” Daya said.
But “a number of differences” exist between the saline study and PolyHeme, he said. “I’m hoping they will not be seen in the same light.” The government, not a private company, funds the saline trial. And only one dose of hypertonic saline will be given; afterward, patients will get more normal saline or, if at a hospital, blood.
OHSU and county review boards have given preliminary approval to the saline study. They will consider final approval once the community notification work ends. Oxman said public health review board members “decided that the study is well designed and that there are no outstanding ethical issues,” Oxman said.
Researchers will take extra steps to make sure the community is notified about the saline trial, Daya said, including special presentations for some minority groups.
One thing researchers and review boards will gauge by talking to community members is whether they should craft a way for people to decline joining the trial, Daya said. Some cities offered bracelets to people who did not want to join the PolyHeme trial, for instance.