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FDA warns against blood transfusion-related injuries

Patient Safety Monitor Alert, October 18, 2004

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Acute lung injury was the most frequent cause of blood transfusion-related deaths in 2003, according to the U.S. Food and Drug Administration (FDA).

Transfusion-related acute lung injury (TRALI) is caused by an antigen-antibody reaction. Antibodies attach to the patient's white blood cells and form microaggregates that end up in the lungs, where they can cause life-threatening vascular permeability and pulmonary edema. Some blood donors are more likely to carry these antibodies than others, including women who have had multiple births and people who have received previous transfusions.

It's important to recognize TRALI in patients who recently received a transfusion, the FDA reminds. The agency outlines ways to recognize and treat the condition in the October edition of its FDA Patient Safety News. Symptoms usually begin within one to two hours after the transfusion and are fully present within six hours. Depending on the severity of the symptoms, patients may require respiratory support. They include:

• shortness of breath
• hypoxemia
• hypotension
• fever
• severe bilateral pulmonary edema

Dealing successfully with TRALI requires vigilance, prompt treatment, and reporting, the FDA reminds.

"First, be alert that any respiratory distress experienced by a patient during or following a transfusion could potentially be TRALI," the agency states. "If you observe respiratory distress, discontinue the transfusion immediately and begin oxygen and supportive therapy. Second, notify your transfusion service. It will arrange for any remaining product to be returned to the blood collecting facility, and for the donor to be tested for the antibodies."

Report any cases of TRALI to the FDA's Center for Biologics Evaluation and Research by calling 301-827-6220 or e-mailing fatalities2@cber.fda.gov.

-- wjohnson@hcpro.com

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