Use of an innovative syringe pump to deliver bolus rFVIIa for patients with haemophilia and inhibitors undergoing surgery

Abstract

Aim: To evaluate the efficacy and safety of using a syringe driver perfusor pump to deliver frequent regular bolus doses of rFVIIa peri- and postoperatively to patients with severe haemophilia and inhibitors. Background: The provision of surgical haemostatic coverage with rFVIIa requires regular bolus doses, initially every two hours and subsequently three-hourly, moving to four- to six-hourly post-operatively. This has implications for safety and nursing time, and can influence clinical decision-making. We investigated the use of an infusion pump to deliver timed and accurate rFVIIa bolus doses during the postoperative period. Methods: Two patients with severe haemophilia A and inhibitors undergoing three procedures were managed with a pre-surgical bolus infusion of 120mcg/kg of rFVIIa, followed by postoperative doses of 90mcg/kg every two hours for the first 72 hours, and every three hours subsequently, with increasing dose intervals thereafter. All postoperative bolus doses were delivered via a pre-programmed infusion pump. The pump also required a constant background infusion set at 0.1ml/ hour for the first patient, and reduced to 0.01ml/hour for the second patient. Results: The pump was simple to use and readily accepted by patients and nursing staff. There were no delayed or missed doses, and good haemostasis was maintained. Overall nursing time involved in reconstituting and administering rFVIIa was reduced from three to six hours per treatment day (with conventional bolus dosing) to just one to two hours per day with the pump. Conclusions: The syringe pump successfully delivered the correct doses at the specified time intervals for all three procedures. The technique met the centre’s safety and efficacy criteria and resulted in a significant reduction in the amount of nursing time needed over a 24-hour period. This novel method of rFVIIa administration appears to be safe and effective in the elective surgery setting, and should be further investigated.

Eptacog Alfa (Activated) Is Physically and Chemically Stable over 24 Hours when Administered as Bolus Injections in an Automated Infusion Pump

“…However, the wealth of clinical experience with rFVIIa and the use of established pump technology indicate that this is a valid option for delivery of rFVIIa, with the potential to increase convenience and reduce the time burden associated with dosing. 3…”

“…Delayed or missed doses, which can inadvertently occur on a busy hospital ward, can lead to impaired hemostasis. 3 For surgical patients in the perioperative period, failure to administer rFVIIa at the designated time intervals may increase the risk of breakthrough bleeding and result in poor patient outcomes. 4…”

Principles of care for acquired hemophilia

“…Where rFVIIa is concerned, treatment feasibility might be enhanced by using an infusion pump method designed to deliver timed, accurate bolus doses. 28 However, this novel delivery method is not currently widely available for routine use. For rpFVIII, a validated laboratory assay for monitoring treatment is important.…”

Successful use of recombinant activated factor VII administered via automated bolus pump following emergency laparoscopic appendectomy in a patient with mild congenital FVII deficiency: Case report

“…1,3,4,7 Patients who undergo surgery therefore require regular and frequent perioperative and postoperative bolus doses of replacement therapy, 2,8 which involves considerable nursing time and hospital resources to ensure optimal hemostatic management. 9 Eptacog alfa (activated) (NiaStase RT) is a recombinant activated FVII (rFVIIa) used for the treatment of bleeds and perioperative management in patients with approved bleeding disorders, including FVII deficiency. 10,11 rFVIIa has been used for successful perioperative hemostasis in patients treated with manually administered rFVIIa.…”

“…[3][4][5]7,8,[12][13][14] However, the use of an infusion pump represents a convenient method of delivering frequent bolus rFVIIa doses to patients undergoing surgery. 9 Here, we report the use of an automated bolus infusion pump (Figure S1) 9,15,16 to deliver timely and accurate bolus rFVIIa doses for perioperative hemostasis in a patient with congenital FVII deficiency undergoing emergency laparoscopic appendectomy. Hemostasis outcome and treatment burden from a nursing and patient perspective were evaluated.…”