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Originally published Friday, March 27, 2009 at 12:00 AM

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Disputed nationwide trauma treatment ends

A key part of a project that has been testing experimental treatments on trauma victims nationwide, including in Seattle, has been shut down after the researchers discovered one new therapy offered no benefit and patients receiving it appeared to die more quickly.

WASHINGTON — A key part of a project that has been testing experimental treatments on trauma victims nationwide, including in Seattle, has been shut down after the researchers discovered one new therapy offered no benefit and patients receiving it appeared to die more quickly.

The research has been subject to intense ethical debate because the patients, who were often unconscious or disoriented because of their injuries, could not give consent to participate.

More analysis will be needed to examine why there were more deaths initially among the patients receiving the experimental treatment, a concentrated form of a salt solution that was being tested in seriously injured patients who were in shock from severe blood loss, federal officials said Thursday.

They stressed there was no overall longer-term increase in deaths among the patients receiving that therapy and the study was halted primarily because it failed to meet a higher standard required for experimenting on patients without their consent: providing a clear benefit over standard care.

"There was high hope based on all the evidence at the time we designed the study that this would be beneficial," said George Sopko, of the National Heart, Lung, and Blood Institute, which sponsored the research. "But we found that there was no chance it was going to be better, so it would have been unethical to continue."

Critics, however, said the results illustrated why such research is unethical and called for the government to shut down two other large studies that are part of the same project.

"They shouldn't be doing these kinds of studies," said George Annas, a Boston University bioethicist. "You shouldn't be doing research on people without their consent. People have a right not to have the government invade their body."

The saline study was one of four related trials being conducted as part of a $50 million, five-year, federally funded project, the most ambitious set of studies mounted under a federal exemption that allows researchers to conduct some kinds of medical experiments without getting patients' informed consent.

Two of the trials tested stronger saline solution on two groups: shock victims and traumatic brain-injury patients. In addition, researchers at the University of Washington and elsewhere are conducting two other trials on cardiac patients: one to assess the duration of CPR before starting defibrillation and the other to test a device that speeds the flow of blood to the heart.

Only the saline study involving shock patients has been stopped, said Dr. Eileen Bulger, a trauma surgeon at Harborview Medical Center and the lead local investigator on the two saline trials.

The UW is one of 10 sites nationwide that was studying more than 20,000 people to improve treatment for trauma and cardiac patients.

Bulger said that before the study was stopped, paramedics gave the stronger saline solution to 199 shock patients at Harborview. An additional 274 local brain-injury patients, whose trial continues, were also given the solution.

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Because such patients are usually unconscious at a time every minute counts, it is often difficult if not impossible to get consent from them or their families.

"In these situations, where someone has collapsed or is about to die, you are not going to have a chance to ask for consent, because minutes matter," Sopko said.

Although the project was endorsed by many trauma experts and some bioethicists, others questioned it, noting that attempts to test treatments such as blood substitutes under the same exemption may have put patients at risk.

The study that was halted was designed to involve about 3,700 patients who were in shock as a result of severe bleeding. Typically, emergency medical workers infuse such patients with a normal-strength saline solution in the ambulance until they can get to the hospital to receive blood transfusions. Some research, however, has suggested the highly concentrated saline might be superior, either by itself or combined with another substance known as dextran.

The study was suspended on Aug. 25, when an independent panel monitoring the project found that after an average of 28 days, there was no difference in the death rates between those receiving concentrated saline and those receiving normal saline, which was the study's predetermined measure of success. Moreover, more patients receiving concentrated saline died on their way to the hospital or in the emergency room, officials said.

Sopko did not release additional details, saying more analysis is needed. But he said the lack of excess deaths after 28 days indicated that the treatment, while not superior, had not harmed patients.

"The key is you want to see whether the patient leaves the hospital or is alive after 28 days," he said.

Annas, however, said the findings suggest the therapy may have harmed study participants.

"So they're saying it doesn't matter when you die; it doesn't matter if you die today or in 28 days, that the last 28 days of life are not important?" Annas said. "That's ridiculous."

Bulger said "we don't believe that the saline itself is causing the deaths."

Investigators suspect instead that the stronger saline may be reviving the patients and making them appear less ill, leading doctors to ease up on vigilance.

Seattle Times health reporter Kyung Song contributed to this report.

Copyright © 2009 The Seattle Times Company

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