Hopkins Joins New U.s. Blood Safety Net

Hospital To Help Catalog Transfusion Dangers

April 19, 2009|By Robert Little | Robert Little,robert.little@baltsun.com

The Johns Hopkins Hospital and a handful of other medical centers around the country are set this week to begin collectively monitoring and tracking dangerous reactions to blood transfusions, the first piece of a nationwide "biovigilance" program that is arriving in the United States years later than in most other developed nations.

The ultimate goal of the project, a collaboration between federal agencies and private medical associations, is to reduce the number of infections, allergic reactions, clerical errors and other complications related to blood transfusions. Such complications resulted in at least 46 deaths in the U.S. last year.

But physicians also call it a long overdue effort to better understand the risks of a common medical practice - more than 30 million blood products are transfused in the United States each year - that has scarcely been evaluated on a large scale.

The monitoring system also comes as civilian hospitals have increased use of plasma - among the riskiest blood components - to treat injured patients, based on treatments used by military doctors in Iraq.

"We've sort of fallen behind efforts in the rest of the world," said Dr. Paul Ness, director of transfusion medicine at Hopkins, one of nine institutions participating in a pilot study that organizers hope to implement nationwide in the fall.

"We'd like to be able to educate recipients about potential risks, but what, really, is the incidence of these reactions? We don't know," Ness said.

Blood transfusions are fairly routine treatments for cancer patients, trauma victims, surgery patients and other hospital patients. At Hopkins, Ness said, doctors transfuse roughly 45,000 units of the most common blood component each year.

Serious complications are rare. The number of annual deaths attributed to transfusion reactions nationwide declined to 46 last year, from 52 the year before and 63 in 2006.

But deaths, which are required to be reported to the Food and Drug Administration, are only one measurement of safety, said Dr. Matthew Kuehnert, director of the Centers for Disease Control and Prevention's Office of Blood, Organ and Other Tissue Safety. Things like allergic reactions or treatable infections can have a huge effect on the cost and the outcome of a patient's medical treatment, Kuehnert said, yet doctors know very little about the scope or the frequency of such reactions because there is no nationwide monitoring program.

"People see blood as being safe, and it is - very safe," said Kuehnert, whose agency is managing the data collection effort. "But there are still reactions, and some of them can be prevented."

The monitoring program, which is voluntary, asks hospital blood banks to report information about bad reactions or other incidents to a central databank. Most hospitals record such information anyway, but agreement on a universal set of definitions and reporting requirements eluded the program's organizers for more than three years. A main goal of the pilot program is to determine how much work the program will require.

Transfusion specialists have talked for decades about creating a national monitoring program, but because of the United States' fractionated health care system - with no central, regulated institution responsible for blood collection and distribution - little has been done. Countries with nationalized or heavily regulated health systems acted first, and their findings have already led to changes in transfusion practices worldwide.

The British program, for instance, determined after several years of data collection that a rare but deadly reaction called Transfusion Related Acute Lung Injury was linked to plasma from female donors who had once been pregnant. Many of the world's blood banks subsequently shifted to male-only plasma, and cases of TRALI declined.

Organizers say an American system could have a considerable impact on global practice, if only because of its potentially massive size. So far roughly 15 percent of the country's hospitals have agreed to participate when the program is rolled out nationwide. And according to Barbee Whitaker, director of data and special programs for the American Association of Blood Banks, the program would still be the largest in the world if 10 percent signed up .

Debates about transfusion risks are common among civilian blood bankers and trauma specialists today, in light of a controversial but potentially groundbreaking practice that emerged from combat hospitals in Iraq.

Military doctors who treated patients in Iraq and studied data from the war zone have promoted a fourfold increase in the standard dose of transfused plasma for trauma patients. Military leaders consider it the most significant medical lesson of the war.

The military practice, widely adopted among civilian hospitals, is thought by some to prevent many trauma-related complications before they develop. But plasma has also been implicated in TRALI and other complications.

The monitoring program can't determine whether a particular component or transfusion strategy is effective, Ness said, but it can help establish the relative risks of plasma and other components and track the frequency of complications around the United States.

The program will also track less serious concerns, such as minor allergic reactions or the use of expired blood. Individual hospitals could use the data to identify weaknesses and measure themselves against a national standard, Kuehnert said.

"All of these events are pretty rare in any one hospital, so it's hard for someone to make improvements based on something they might only see happen once," said Whitaker, the blood bank official. "But once we know what's there, we can talk about how we prevent it from happening again."

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