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Perioperative safety and haematostatic efficacy of a new bypassing agent pd-FVIIa/FX (Byclot) in haemophilia patients with high-responding type inhibitors.
- Source :
-
Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis [Blood Coagul Fibrinolysis] 2019 Dec; Vol. 30 (8), pp. 385-392. - Publication Year :
- 2019
-
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.
- Subjects :
- Adult
Drug Combinations
Drug Therapy, Combination adverse effects
Factor VIIa adverse effects
Factor X adverse effects
Hemophilia A immunology
Hemophilia B immunology
Hemorrhage prevention & control
Hemostatics adverse effects
Hemostatics therapeutic use
Humans
Male
Perioperative Care adverse effects
Retrospective Studies
Surgical Procedures, Operative adverse effects
Surgical Procedures, Operative methods
Surgical Procedures, Operative standards
Thrombosis chemically induced
Treatment Outcome
Young Adult
Factor VIIa therapeutic use
Factor X therapeutic use
Hemophilia A drug therapy
Hemophilia B drug therapy
Hemostatics standards
Perioperative Care methods
Subjects
Details
- Language :
- English
- ISSN :
- 1473-5733
- Volume :
- 30
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis
- Publication Type :
- Academic Journal
- Accession number :
- 31738288
- Full Text :
- https://doi.org/10.1097/MBC.0000000000000851