Thursday, Oct. 30, 2008 | Citing concerns about safety, the federal government has halted an unusual medical study in San Diego County that tests intravenous liquids on trauma patients without their consent.

Federal officials haven’t disclosed why they’re concerned about the study, which requires paramedics to randomly assign certain trauma patients to receive different types of saline solution through intravenous drips. San Diego County is one of 10 communities in the U.S. and Canada that are taking part in the research, designed to reveal how best to treat patients with blood loss as they’re transported to the hospital. Officials stopped in the study in all 10 communities.

A similar study that tested an artificial blood product on unknowing

trauma patients in San Diego and elsewhere was criticized by a U.S. senator and others who didn’t think researchers had done enough to alert members of the public that they may be “guinea pigs.” But local health officials support the new research and hope they’ll be able to restart the IV study soon.

The suspension of the study “doesn’t mean anything serious is going on or that anyone has done anything wrong,” said Dr. Jim Dunford, medical director of the city of San Diego. “Everyone would be flabbergasted if it was anything serious.”

There’s no indication of whether the study has inadvertently harmed trauma patients.

The study has immersed local medical officials — including the ethics review boards of about a dozen hospitals that approved the study — in an ongoing debate over how to best conduct research in the emergency-medicine field.

Researchers routinely obtain consent from patients before enrolling them in studies designed to test medical strategies. But patients who have been severely hurt in traumas like car accidents are often unconscious or in shock and unable to agree to be in a study.

“It’s not practical to perform an informed consent, and obviously (researchers) are not around,” said Dr. Daniel Davis, professor of clinical medicine at the University of California, San Diego and principal investigator for the local efforts of the IV-drip study.

In 1996, the Food and Drug Administration lifted rules about informed consent for research involving emergency medicine.

Since then, several studies have taken advantage of the emergency-medicine loophole, including one that has drawn intense attention nationally.

From 2004 to 2006, UCSD Medical Center and Scripps Mercy Hospital — along with dozens of other hospitals nationwide — took part in a study of an artificial blood product called Polyheme.

Bioethicists, doctors and U.S. Sen. Charles Grassley of Iowa criticized the study because patients unknowingly received an unproven fake blood product instead of the real thing. People could only opt out of the study if they heard about it and requested a special bracelet. The manufacturer of the fake blood product also came under fire for allegedly hiding the results of a study that suggested the blood product caused heart attacks in some patients.

The new IV fluid studies also take advantage of the federal-law loophole to bypass informed-consent requirements. Without their knowledge, local trauma patients who meet the criteria to be in the study are randomly assigned to receive an IV drip of normal saline solution or one of two types of “hypertonic” saline solution.

Paramedics routinely give standard saline solution to trauma patients in order to keep their blood pressure steady until they reach the hospital. But some researchers have questioned whether that’s the best approach, Davis said.

“If you give someone normal saline, a lot of it leaks into the lungs and the brain and causes swelling and difficulty with respiration,” he said. As an alternative, researchers have suggested the side effects could be reduced by using a solution with a higher concentration of salt, Davis said.

The new study aims to determine which kind of saline solution is best in trauma patients. It compares regular intravenous saline solution — 0.9 percent salt — with one solution that’s 7.5 percent salt, Davis said. Patients could also receive a high-salt solution that includes a carbohydrate known as Dextran.

In theory, it’s possible that a higher concentration of saline solution could cause brain damage, Davis said. But the study has shown that isn’t a problem, he said.

On Sept. 12, the National Heart, Lung, and Blood Institute issued a statement saying the government had suspended the study in August because a review board “had concerns about patient safety … relative to the likelihood of showing benefit, which could not be resolved by currently available data.”

Amy Pianalto, a spokesman for the institute, declined to elaborate on the cryptic statement except to say that the review board was concerned about “a trend in a specific subgroup of patients.”

Even those overseeing the study on a local basis don’t know what concerns the review board. “They’re deliberately keeping us in the dark so if whatever concerns they have are addressed with additional data collection, we won’t have been contaminated by finding out any results,” Davis said.

The study began in areas of San Diego County outside the city of San Diego in 2006. The city joined the study last summer before it was suspended.

As of mid-August, 103 local patients took part in the study, Davis said. Another 89 patients were enrolled in a related study that examines use of hypertonic saline solution in emergency patients with brain injury. Researchers have halted that study nationwide until paramedics can be retrained in the wake of the suspension of the other arm of the study.

Health officials have held meetings in the community to alert residents to the study and allow them to request opt-out bracelets that they must wear at all times in case they’re injured. But attendance has been low. One February 2007 meeting in Chula Vista attracted just three people: two reporters and a friend of a reporter.

Other meetings have included politicians. “One thing we’ve tried to do more and more is to keep the political community involved,” Davis said.

Fewer than a dozen people have requested the bracelets that allow people to opt out of the study, he said.

Meanwhile, San Diego paramedics are slated to launch another emergency-medicine study that won’t require consent from patients. This study, which Dunford said is already underway nationally, randomly assigns cardiac-arrest patients to various types of CPR.

According to the American Heart Association, cardiac arrest — in which the rhythm of the heart is disrupted — kills 95 percent of patients.

“We’d like to get going on (the study),” said Dunford, the San Diego medical director, but the city must first demonstrate that its paramedics are proficient in giving CPR.

Randy Dotinga is a San Diego-based freelance writer. Please contact him directly at rdotinga@aol.com with your thoughts, ideas, personal stories or tips. Or set the tone of the debate with a letter to the editor.

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