Is there a Standard Definition of Hypotensive Transfusion Reaction in Neonates for Biovigilance?

A member of the AABB Biovigilance Working Group writes asking for a usable standard definition for Hypotensive Transfusion Reactions for children and neonates.  She forwarded the inquiry:

"I am preparing to enroll in the Hemovigilance Module of the NHSN. I was glad to see that the denominator is units or aliquots. I do have one question. On page 17 "Hypotensive transfusion reactions" are defined as"Drop in systolic and/or diastolic blood pressure of > 30 mm Hg occurring during or within one hour of completing transfusion.

So how should I adapt this to babies? If each hospital makes their own adaption it will not be useful for aggregate data."It appears that hypotension may not be usable as written for neonates, although most of the other proposed definitions are usable.  Are any members aware of accepted definitions of hypotensive transfusion reactions in neonates?

Editor's' Note: Another member of the Working Group comments that definitions in non-adult populations are challenging: "In the ISBT Working Party we deliberately decided to stick to adult case definitions. It was already complicated enough. We are aware that the definitions do not apply to the pediatric population and even less to neonates. We would certainly welcome any help to come up with pediatric and neonatal case definitions for ATRs."  If there are no accepted definitions, are there any proposals for defining hypotensive transfusion reactions in neonates and children?

The following comments have been submitted in response.

ADDENDA July 29, 2009

1. Ron Strauss (attribution used with permission) writes: "Although 'normal' BP values have been published for infants & children, validated measurements for infants - especially preterm neonates - are nonexistent. A study is being planned by a cooperative neonatal study group, so 'normal' values may become available soon. BP recording might be the usual systolic & diastolic or it might be a single mean value. Also, because transfusions are often given at very slow infusion rates to infants, the timing of when the diagnosis of a transfusion reaction is made may need some modification."
   
   He proposes as a draft working definition of a hypotensive transfusion reaction for children and neonates, "At any time during or within one hour of completing the transfusion, when hypotension occurs that is not readily explained by another underlying condition, as defined by any one or all of the following: a) a drop from the baseline/pretransfusion BP of >25%; b) in the absence of a pretransfusion baseline BP, a BP lower than 25% below age-adjusted normal values, or lower than one SD below the mean of age-adjusted normal values. For example, if the age adjusted value is 100mm Hg, then a value below 75 would qualify as hypotensive. To establish the diagnosis, the hypotensive BP measurement must be confirmed by a repeat measurement or, if the BP is being recorded continuously, by persisting for at least one minute. A baseline/pretransfusion BP value requires at least 3 measurements within 15 mins of beginning the transfusion."

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