The Use of Recombinant Factor VIIa (NovoSeven®) for Unexplained Bleeding after Genital Surgery
Danielle A. Velez, MD; Bradley Denardo, MD; Anthony Caldamone, MD; Liza Aguiar, MD
Brown University, Providence, RI
Bleeding is a common risk factor for pediatric penile surgery. Diffuse, significant bleeding, uncontrollable with traditional measures, including electrocautery, compression, and surgical hemostatic agents, is rare, and can be difficult to manage. We present two patients successfully treated with off-label use of recombinant Factor VIIa (rFVIIa, NovoSeven®).
We review the history, hospital course, and subsequent workup of two different patients with uncontrolled, diffuse bleeding during and/or after elective penile surgery, who were successfully treated with off-label use of rFVIIa.
Patient A is a six-month old with a mid-shaft hypospadias. Intra-operative generalized bleeding was uncontrolled with electrocautery, pressure, or surgical hemostatic agents. Pediatric Hematology recommended sending lab work to measure plasma concentration of coagulation factors and platelet function, and the patient was given vitamin K and rFVIIa. The bleeding was controlled, and the hypospadias repair was completed. The patient was discharged home the next day. Despite further hematologic testing, no specific coagulopathy was found.
Patient B is a three-year old presenting for circumcision for phimosis. He returned to the operating room on post-operative day (POD) one for diffuse penile bleeding, which was surgically controlled. He re-presented with excessive bleeding on POD#6, requiring repeat operation. Pediatric Hematology was again consulted, and the patient was treated with rFVIIa and one unit of packed red blood cells for an intra-operative hemoglobin of 6.8, with appropriate response. He was discharged home the next day, and was ultimately diagnosed with Hemoglobin A (Factor VIII deficiency).
Both cases were notable for abnormal, diffuse oozing, not from a focal arterial or venous source. Due to the acute and intractable nature of the bleed, and lack of known coagulopathy risk factors by history, pediatric hematology recommended labwork and off-label use of rFVIIa. Both parents were counseled on thrombus risk with NovoSeven® prior to administration.
As Factor VII is an early initiating factor in the coagulation cascade, rFVIIa should be considered when faced with excessive surgical bleeding of unknown cause. In these patients, we felt the benefit of hemostasis outweighed the risk of thrombosis. Although this complication is rare, we believe our experience with rFVIIa may be useful to other urologic surgeons confronted with unexplained and uncontrollable bleeding in the acute setting.
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