“The literature has shown for a while that adverse donor reactions are significantly higher in young folks,” said Robert Jones, MD, of the New York Blood Center. “Then the media picked up a recent JAMA article on the issue and we began to hear from state regulators .”

Jones went on to say that it is important to remember that the vast majority of blood donations are uncomplicated with no side effects or discomfort. “But,” he added, “in addition to some mild side effects such as bruising and bleeding at the venipuncture site, there also are changes in consciousness and injuries that are more serious and difficult to deal with.” Data from New York Blood Center show a significant relationship between adverse events and age and gender, with the youngest donors and females being the most susceptible to reactions.

To address these and other side effects of donation, Jones suggested areas where measures to reduce reactions may be taken, including the following:

·          Predonation education: Increasing donor awareness of the process and potential side effects, and using caution to avoid alarm while reducing anxiety.

·          Blood drive environment: Carefully considering site selection, drive operational control, progressive recovery areas, donor escorts, predonation hydration areas, refreshment areas and separate areas for donors having reactions.

·          Staff supervision/phlebotomist skill: Recommending special skills and training for high school blood drives.

·          Special interventions: Implementing new donor size and age criteria such as 3,500 ml estimated blood volume, new postdonation efforts such as floor mats for recovering donors, distraction strategies, hydration, applied muscle tension and automated collections.

Some of these measures are supported by scientific evidence and others by experience. Although adverse reactions cannot be eliminated completely, Jones said the task force is focused on reducing donor injuries as a result of reactions.  Current estimates predict about one injury in 200,000 donations. “This is a small number, but it’s important,” Jones said, “because those people aren’t going to come back and donate.”

He explained that efforts made to reduce adverse events in younger donors will have a more significant impact when the results can be better measured and organized, and suggested that AABB’s developing biovigilance program may provide a relevant platform for monitoring donor safety.

Comments from audience members addressed the concept of an “acceptable level of adverse reactions” as well as the potential of modified automated collection practices for donors who experience side effects from traditional whole blood donation. One attendee also shared that in her community some high schools disallowed blood drives after some student donors experienced adverse events. These situations were exacerbated and compounded by local news stories about side effects in younger donors. 

“The bottom line is that we need to wrestle this to the ground and assure the public that blood donation is safe for their kids,” Jones said. “We have a responsibility as a profession to prevent this from getting out of control or we could catastrophically lose a whole donor group.”

Mitigating Another Concern: TRALI
Picking up on the theme of common donor center challenges for physicians, Patricia Carey, MD, of the University of Cincinnati Hoxworth Blood Center, delved into the issue of TRALI. Illustrating the pulmonary and cardiac picture for individuals suffering from TRALI, she noted that many patients have underlying conditions that may make them predisposed to lung injury.

Carey went on to provide definitions for TRALI and explained both the criteria for its diagnosis—which were based on the recommendations of a consensus network—and its epidemiology.

Using radiologic slides, attendees were shown side-by-side images of clear pulmonary fields and those with bilateral infiltrates. “Of course TRALI is never going to be unilateral,” Carey said. “If there are infiltrates, you will see them in all lung fields.” Guiding the group through a chest imaging tutorial, Carey explained how to recognize fluid overload and how it looks different from normal pulmonary histology.

The “key players” in TRALI, she said, include neutrophil, pulmonary endothelium and complement activators. “Different algorithms have been put together to sort out the pathophysiology of TRALI,” Carey said. “In the meantime, we’ll outline the two-hit theory as well as the model we’re more familiar with, the immune-mediated process.”

Addressing approaches to posttransfusion differential acute pulmonary edema, Carey explained that facilities will often use various methods, with some mistakenly believing that the laboratory can help them make the diagnosis. “It’s really a clinical diagnosis,” she said.

Transitioning to a focus on the treatment and, most important, the prevention of TRALI, Carey said that it is important to work with transfusion services to ensure quality of care. “We need to make sure no one is overusing products, particularly plasma,” she said. “Internally, you need to monitor your usage and decide what is best for your practice.” As for treatment, Carey noted that it must be supportive of a patient’s respiratory and hemodynamic status.

Carey used the real-time audience voting capabilities to poll attendees on their respective TRALI practices. Results showed that 83% of facilities represented are following a TRALI reporting plan and 73% are using a consensus definition.  When asked how suspected TRALI cases are reported, 59% of facilities said they use a form, 28% rely on free flow of information and 8% maintain a TRALI policy but no form.  “A form really does help,” Carey said. “Free flow of information often produces a lot of cases that aren’t TRALI, but if you have a form with a definition and concrete information, you will promote better, quality reporting of cases.”

The majority of facilities represented in the session say they see no more than 10 cases of possible TRALI each year, but admit that the number of possible cases is not proportionate to the number of units released. This situation can be remedied, in part, by educating nurses and clinicians on how to recognize TRALI.

A polling question about whether or not donor investigations are initiated for cases of possible TRALI found that 78% percent of facilities represented investigate all of the time, 12% never investigate, and 10% investigate some of the time. “AABB says we need to do something, so if you are not doing a workup, what are you doing to evaluate these donors?” Carey asked. 

Results of the extended voting session produced a variety of comments and questions from audience members, many of whom disagreed on whether or not to defer female donors implicated in TRALI who have previously “clean” transfusion records.

Questions are easier to come by than firm answers to these dilemmas, Carey concluded, a challenge complicated by the many management issues associated with TRALI. “One of the things we’ve observed is that we have a lot of practices to manage the situation but all of us are trying to manage the loss of donors and making sure we have enough supplies, too. This is a very real balance,” Carey said. “If you’re going to test parous females, are you going to test just those with four pregnancies or more, or test them all? The other thing that comes into play other than who to test is how you’re going to test.  There are problems translating data as well. How do you determine a range of cut-offs? If I’m screening, are these data I can put back into my donor management system? These types of decisions make for lots of problem solving and create a nightmare for managing donors in these settings. These are the nuts and bolts of the challenges we face,” Carey concluded.

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