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

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®; Baxa...

Full description

Saved in:
Bibliographic Details
Published in:Haemophilia : the official journal of the World Federation of Hemophilia 2021-05, Vol.27 (3), p.e331-e339
Main Authors: Pabinger, Ingrid, Mamonov, Vasily, Windyga, Jerzy, Engl, Werner, Doralt, Jennifer, Tangada, Srilatha, Spotts, Gerald, Ewenstein, Bruce
Format: Article
Language:English
Subjects:
Adverse events
Body weight
clinical trial
Coagulation factors
Erythrocytes
Factor VIII deficiency
haemophilia A
Hemophilia
intravenous infusion
Original
orthopaedic surgery
Orthopedics
Patients
recombinant factor VIII
Surgery
Surgical drains
Wound drainage
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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) through postoperative day 7. Primary outcome measure was cumulative packed red blood cell (PRBC)/blood volume in the drainage fluid within 24 h after surgery, used to establish non‐inferiority of CI to BI. Results CI:BI ratio of cumulative PRBC volume in the 24‐h drainage fluid was 0.92 (p‐value
ISSN:1351-8216
1365-2516
DOI:10.1111/hae.14219