Abstract Number: PB0946
Meeting: ISTH 2020 Congress
Background: rVIII-SingleChain (single chain Factor VIII) is a B-domain truncated recombinant factor comprised of covalently bonded FVIII heavy and light chains. The AFFINITY development program confirmed efficacy and safety of rVIII-SingleChain for the treatment and prophylaxis of bleeding in severe haemophilia A patients, including in the surgical setting.
Aims: To report a real-world experience of the use of rVIII-SingleChain in a case of orthopedic major surgery.
Methods: rVIII-SingleChain dosing regimen was adjusted in perioperative setting (pre-surgery until 14 day after surgical procedure) based on type of surgery and clinical status of patient. The haemostatic efficacy was rated by using a 4-point scale (excellent, good, moderate, poor/no response) adapted from WFH guidelines for the assessment of haemostasis. A haemostatic efficacy rating of Excellent was assigned when haemostasis was not clinically significantly different from normal and blood loss was not > 20% higher than the predicted for the intended surgery.
Results: In July 2018, a 66 years old man affected by severe haemophilia A and comorbities, such as hypertension and hepatitis C, switched to rVIII-SingleChain from a previous rFVIII. An on-demand regimen was maintained until surgery. In October 2019, the patient underwent a major surgery for hip replacement. rVIII-SingleChain was administered as a bolus in surgical prophylaxis. The pre/intraoperative consumption was 93 IU/kg (62 IU/kg pre- and 31 IU/kg 12 hrs post-surgery). Total rVIII-SingleChain perioperative consumption was 690 IU/kg with a total of 18 infusions. Optimal FVIII trough levels were maintained. No unplanned transfusions and no adverse events were reported. Overall, haemostatic efficacy of rVIII-SingleChain was rated as Excellent. After this surgery a prophylaxis regimen was introduced.
Conclusions: In line with results obtained during the AFFINITY trial, this case report reinforced that rVIII-SingleChain is safe and effective to achieve and maintain haemostatic control during orthopedic surgical prophylaxis in haemophilia A patients.
To cite this abstract in AMA style:Dainese C, Valeri F, Agnelli Giacchello J, Valpreda A, Megaterio S, Massé A, Boccadoro M, Borchiellini A. Haemostatic Efficacy of rVIII-SingleChain in a Case of Surgical Prophylaxis for Hip Replacement [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/haemostatic-efficacy-of-rviii-singlechain-in-a-case-of-surgical-prophylaxis-for-hip-replacement/. Accessed February 27, 2024.
« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/haemostatic-efficacy-of-rviii-singlechain-in-a-case-of-surgical-prophylaxis-for-hip-replacement/