Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine^® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Abstract

While coagulation factor replacement is essential in surgical intervention in haemophilia B patients, few studies are available on the safety and efficacy of plasma-derived factor IX (FIX) for haemostasis during surgery. This retrospective study examined outcomes in these patients. A total of 20 patients who underwent 29 surgical procedures at the Hemophilia Treatment Center at Orthopaedic Hospital in Los Angeles, California, were identified and their inpatient charts were reviewed and abstracted. Outcomes included pre- and postoperative FIX dosing, recovery of FIX, blood loss, use of blood products, safety and haemostatic response. Identified patients had mild (10%), moderate (15%) or severe (75%) haemophilia B, and average age at surgery was 48.5 years. All surgical procedures were major (orthopaedic 89.7%; abdominal 10.3%), all were completed under general anaesthesia, and average time in surgery was 3.25 h. Average hospital length of stay was 11.0 days [standard deviation (SD) = 8.5] and all patients were discharged home. All patients were treated with AlphaNine® SD at an average dose of 254.9 IU kg(-1) (SD = 65.4) on the day of surgery and the dose was adjusted over the course of hospital stay. Mean perioperative blood loss was 255.5 mL (SD = 283.1) and blood replacement was required in only two surgeries (6.9%). FIX recovery analysis performed preoperatively related well to FIX levels obtained. Identified patients had little blood loss perioperatively and had no bleeding related complications. Plasma-derived FIX pre- and postoperatively appeared to be a safe and effective treatment in haemophilia B patients undergoing surgery.

Long‐acting recombinant factor IX Fc fusion protein (rFIXFc) for perioperative management of subjects with haemophilia B in the phase 3 B‐LONG study

“…In all 3 subjects, perioperative haemostasis was maintained with prolonged dosing intervals and decreased factor consumption compared with those reported in the literature for other FIX therapies used during similar surgeries (Ragni et al , ; Quon & Logan, ).…”

Efficacy of factor IX Grifols® in surgery: experience of an international multicentre retrospective study

“…The length of stay in the hospital was 7 days on average (9 days in major surgeries and 2 days in minor surgeries, with a range of 2-18 days and 0-5 days respectively), which can be considered normal in comparison with other surgery studies [3]. No unexpected blood loss and no evidence of thrombosis were observed from the use of FIX Grifols ® during these surgical interventions.…”

“…Both treatments have been reported to be safe and efficacious in the treatment of haemorrhages and during surgery in haemophilia B patients [1,2]. In a recent single centre retrospective study, pre-and post-operative treatment with a pdFIX (AlphaNine ® SD; Grifols Biologicals Inc., Los Angeles, CA, USA) was found safe and effective in haemophilia B patients undergoing surgery [3].…”

Perioperative management of haemophilia B: A critical appraisal of the evidence and current practices

“…There are varying outcome measures that have been used to assess the success of perioperative management in haemophilia patients: haemostatic outcome, rate of treatment complications (eg postoperative bleeding, wound infections) and treatment mortality …”