Abstract Number: PB0881
Meeting: ISTH 2020 Congress
Background: Managing patients with HA undergoing major surgery requires maintaining factor VIII (FVIII) activity at target levels. pathfinder 3 assessed N8-GP, an extended half-life glycoPEGylated recombinant FVIII, during major surgery in patients (≥12 years) with severe HA. Informed consent was obtained; the study was approved by relevant ethics committees. Thirty-five patients undergoing 49 surgeries were included: haemostasis was successful (defined as an ‘excellent’ or ‘good’ response) in 47/49 (95.9%) surgeries (two had a ‘moderate’ response) with reduced dosing frequency (Hampton et al, WFH-MSK, 2019; ISTH symposium, Thromb. Haemost., 2019; Novo Nordisk data on file).
Aims: To report intraoperative haemostatic response of three patients undergoing multiple (n=11) major surgeries in pathfinder 3.
Methods: Patients received peri-operative N8-GP for surgery and were assessed over the surgical period: d0, once daily (d1-6); and once during d7-14. Surgical procedure, haemostatic response, N8-GP consumption and adverse events (AEs) were reported. Haemostatic response was defined as follows: excellent, better than expected; good, as expected; moderate, less than optimal but response maintained; poor, bleeding due to inadequate response (regimen change required to restore haemostasis).
Results: A 50-year-old patient (patient 1) underwent three consecutive, elective procedures; a 57-year-old patient (patient 2) underwent four consecutive procedures (two elective, two emergency); and a 30-year-old patient
(patient 3) underwent four consecutive elective procedures (Table 1). Haemostasis was successful for all surgeries. N8-GP consumption was per-protocol during the operative period; no procedures required an intra-operative dose of N8-GP. N8-GP was well tolerated; all AEs reported for patients 1 (n=7) and 2 (n=5) were mild and unrelated to treatment; no AEs were reported for patient 3.
Conclusions: N8-GP is effective and convenient with a good safety profile when used during surgery in patients with severe HA undergoing multiple major procedures.
To cite this abstract in AMA style:Hampton K, Clausen WHO, Benchikh El Fegoun S, Landorph A. Successful Multiple Surgeries in Adult Patients with Haemophilia A (HA) Treated With Turoctocog Alfa Pegol (N8-GP) in the Pathfinder 3 trial [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/successful-multiple-surgeries-in-adult-patients-with-haemophilia-a-ha-treated-with-turoctocog-alfa-pegol-n8-gp-in-the-pathfinder-3-trial/. Accessed November 30, 2023.
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