1. 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
- Author
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Vasily Mamonov, Bruce Ewenstein, Jerzy Windyga, Srilatha Tangada, Jennifer Doralt, Ingrid Pabinger, Gerald Spotts, and Werner Engl
- Subjects
Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Haemophilia A ,Knee replacement ,haemophilia A ,Blood volume ,030204 cardiovascular system & hematology ,Hemophilia A ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Orthopedic Procedures ,intravenous infusion ,Clinical Haemophilia ,Adverse effect ,Genetics (clinical) ,Hip surgery ,Hemostasis ,recombinant factor VIII ,Factor VIII ,business.industry ,clinical trial ,Original Articles ,Hematology ,General Medicine ,Perioperative ,medicine.disease ,Recombinant Proteins ,Confidence interval ,Anesthesia ,Orthopedic surgery ,Original Article ,orthopaedic surgery ,Blood Coagulation Tests ,business ,030215 immunology - 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) 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
- Published
- 2021