Results of a randomized phase III/IV trial comparing intermittent bolus versus continuous infusion of antihaemophilic factor (recombinant) in adults with severe or moderately severe haemophilia A undergoing major orthopaedic surgery.

ABSTRACT:

Introduction

In patients with haemophilia A undergoing surgery, factor VIII (FVIII) replacement therapy by continuous infusion (CI) may offer an alternative to bolus infusion (BI).

Aim

To compare the perioperative haemostatic efficacy and safety of antihaemophilic factor (recombinant) (ADVATE^® ; Baxalta US Inc., a Takeda company, Lexington, MA, USA) CI or BI administration.

Methods

In this multicentre, phase III/IV, controlled study (NCT00357656), 60 previously treated adult patients with severe or moderately severe disease undergoing elective unilateral major orthopaedic surgery (knee replacement, n = 48; hip surgery, n = 4; other, n = 8) requiring drain placement were randomized to receive antihaemophilic factor (recombinant) CI (n = 29) or BI (n = 31) th

SUBMITTER: Pabinger I 

PROVIDER: S-EPMC8252548 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature