Perioperative safety and haematostatic efficacy of a new bypassing agent pd-FVIIa/FX (Byclot) in haemophilia patients with high-responding type inhibitors

Rie Shirayama, Hideyuki Takedani, Yushi Chikasawa, Akira Ishiguro, Masataka Ishimura, Kiyotaka Isobe, Mitsuhiro Uchiba, Yoshiyasu Ogata, Harumi Kakuda, Koichi Kusuhara, Akira Shirahata

Research output: Contribution to journalArticle

Abstract

The novel agent pd-FVIIa/FX is a 1:10 protein weight mixture of activated factor VII (FVIIa) and factor X (FX) derived from donated blood plasma. A phase III clinical trial of pd-FVIIa/FX revealed high efficacy for bleeding episodes in haemophilia patients with inhibitors. However, up to now, only one case of this new agent being used for surgery had been reported. The objective of this study is to evaluate the perioperative haemostatic efficacy and safety of pd-FVIIa/FX in haemophilia patients with inhibitors. We retrospectively reviewed 25 operation charts from 14 haemophilia patients with high-responding inhibitors using pd-FVIIa/FX during the perioperative period. Efficacy was evaluated by attending physicians and results divided into four groups (excellent, good, fair, and poor). The operation chart was provided by nine Japanese medical institutes with expertise in haemophilia management. Out of the total of 25 surgical procedures, 44% (11/25) were classified as major surgery and the remainders were minor surgeries. In all of the surgeries but one, rFVIIa and/or APCC were administered in combination or sequential method. In all cases except one, the haemostatic efficiency rate was judged as excellent or good by treating physicians for an overall efficacy rate of 96%. No thrombotic adverse effects were reported. This study's results suggest that both combination and sequential therapy of pd-FVIIa/FX and other bypassing agents are well tolerated and effective for the control of perioperative bleeding in haemophilia patients with high-responding inhibitors.

Original languageEnglish
Pages (from-to)385-392
Number of pages8
JournalBlood Coagulation and Fibrinolysis
Volume30
Issue number8
DOIs
Publication statusPublished - Dec 1 2019

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Factor X
Hemophilia A
Safety
Hemostatics
Hemorrhage
Physicians
Minor Surgical Procedures
Factor VIIa
Phase III Clinical Trials
Perioperative Period
Weights and Measures
Proteins

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

Perioperative safety and haematostatic efficacy of a new bypassing agent pd-FVIIa/FX (Byclot) in haemophilia patients with high-responding type inhibitors. / Shirayama, Rie; Takedani, Hideyuki; Chikasawa, Yushi; Ishiguro, Akira; Ishimura, Masataka; Isobe, Kiyotaka; Uchiba, Mitsuhiro; Ogata, Yoshiyasu; Kakuda, Harumi; Kusuhara, Koichi; Shirahata, Akira.

In: Blood Coagulation and Fibrinolysis, Vol. 30, No. 8, 01.12.2019, p. 385-392.

Research output: Contribution to journalArticle

Shirayama, R, Takedani, H, Chikasawa, Y, Ishiguro, A, Ishimura, M, Isobe, K, Uchiba, M, Ogata, Y, Kakuda, H, Kusuhara, K & Shirahata, A 2019, 'Perioperative safety and haematostatic efficacy of a new bypassing agent pd-FVIIa/FX (Byclot) in haemophilia patients with high-responding type inhibitors', Blood Coagulation and Fibrinolysis, vol. 30, no. 8, pp. 385-392. https://doi.org/10.1097/MBC.0000000000000851
Shirayama, Rie ; Takedani, Hideyuki ; Chikasawa, Yushi ; Ishiguro, Akira ; Ishimura, Masataka ; Isobe, Kiyotaka ; Uchiba, Mitsuhiro ; Ogata, Yoshiyasu ; Kakuda, Harumi ; Kusuhara, Koichi ; Shirahata, Akira. / Perioperative safety and haematostatic efficacy of a new bypassing agent pd-FVIIa/FX (Byclot) in haemophilia patients with high-responding type inhibitors. In: Blood Coagulation and Fibrinolysis. 2019 ; Vol. 30, No. 8. pp. 385-392.
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