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Safety Of Pre-operative Epoetin Alpha In Surgical Calvarial Remodeling: An 8 Year Retrospective Review And Analysis

Sanjay Naran, MD, Franklyn Cladis, MD, Jeffrey Fearon, MD, James Bradley, MD, Brett Michelotti, MD, Gregory Cooper, PhD, James Cray, Jr., PhD, Christopher Kinsella, MD, Hurig Katchikian, BS, Rachel Mi
University of PIttsburgh Medical Center, Children's Hospital of Pittsburgh
2010-03-21

Presenter: Sanjay Naran

Affidavit:

Director Name:

Author Category: Resident/Fellow

BACKGROUND & PURPOSE:
Calvarial remodeling is a complex, high blood loss procedure. Pre-operative Epoetin has proven to decrease the need for blood transfusions; however, recent studies have raised concern that elevating hemoglobin levels >12.5 g/dl may increase the risk of thrombotic events. It was therefore necessary to identify any such risk in our population. We sought to review patients who underwent calvarial remodeling after receiving Epoetin, determine the incidence of any thrombotic events, and establish that the use of Epoetin does not pose the same risk of morbidity as in other groups.

METHODS:
Three major metropolitan children's hospitals were retrospectively reviewed for patients who underwent calvarial remodeling after receiving Epoetin between 2000-2008. Demographic and peri-operative data were collected, with attention paid to deep vein thrombosis, cerebrovascular accident, pulmonary embolism, sagittal sinus thrombosis, myocardial infarction/ischemia, and mortality.

RESULTS:
369 patients qualified (average age = 0.81±1.1 yrs). Epoetin was administered at 600U/kg, with an average course of three doses. There were no major complications (i.e. death or blindness). 26 patients (7.05%) experienced minor complications (i.e. respiratory distress requiring breathing treatments). There were no instances of any thrombotic events. There was no correlation between hemoglobin levels >12.5 g/dl and the occurrence of any complication.

CONCLUSIONS:
We observe zero thrombotic post-operative complications, and infer the risk of any thrombotic event in this population to be at most 1.14% (95% confidence). Taken together, these data show that Epoetin dosing does not correlate with an increase in thrombotic events, and remains a safe pre-operative therapy.

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