Continuous infusion during total joint arthroplasty in Japanese haemophilia A patients: comparison study among two recombinants and one plasma‐derived factor VIII

Abstract

As for the available factor VIII (FVIII) concentrates in Japan, there are two recombinant FVIII concentrates (Kogenate-FS and Advate) and one highly purified plasma-derived FVIII concentrate (Cross-Eight M). To evaluate the inter-product variability, the differences in the continuous infusion rates and total consumption of the above three concentrates were compared when continuous infusion was used as the administration mode to control bleeding during 28 total joint arthroplasties (TJAs) for 17 patients. There were no significant differences among the FVIII plasma levels during surgery, except day 0. Advate needed to be given at a significantly higher infusion rate (4.2-2.1 IU kg(-1) h(-1)) than the other two concentrates (Kogenate-FS: 1.0-2.9 IU kg(-1) h(-1), P < 0.01 and P < 0.05; Cross-Eight M: 3.2-1.8 IU kg(-1 )h(-1), P < 0.01); however, their infusion rates were within the rates which were previously reported. The total consumption of Advate (652.1 IU kg(-1)) was also significantly greater than either of the other concentrates (Kogenate-FS: 395.1 IU kg(-1), P < 0.01; Cross-Eight M: 519.1 IU kg(-1), P < 0.05). The results of this study showed that the continuous infusion of three FVIII concentrates is effective and safe during TJA, and also showed the differences in the continuous infusion rates and total consumption among concentrates when continuous infusion was used to control bleeding during surgery. These two results suggested that the continuous infusion of FVIII concentrate is a good administration mode, but there is still room for further investigation to use it as a more cost-effective and safer administration mode.

Continuous infusion of recombinant factor VIII formulated with sucrose in surgery: Non‐interventional, observational study in patients with severe haemophilia A

“…This study confirms previous research of efficacy of CI in the surgery setting of severe haemophilia A patients . Despite some observed obstacles due to venous access and laboratory measurement issues, which could also occur with bolus injections, CI administration is feasible in real clinical practice if applied according to local protocols and the product information.…”

Seventy‐two total knee arthroplasties performed in patients with haemophilia using continuous infusion

“…[11] in 1970, continuous infusion of CFC represents multiple benefits. Several studies showed that CI is a safe and effective method [23, 35]. The stability and microbiologically safety of CFC at room temperature were also demonstrated [36, 37].…”

Continuous Infusion of Coagulation Products in Hemophilia

“…The Japanese guideline for hemophilia treatment suggest to use CI for major surgery [35,36]. Many reports demonstrated CI to be safe and hemostatically effective for all indications mentioned above, including the most demanding surgical procedures [1,2,[4][5][6][7]20,[34][35][36][37][38]. Most recently Takedani [37], Rahmé et al [38], and Chevalier et al [39] reported on successful use of CI in 28, 20, and 72 total knee replacements, respectively.…”

“…Many reports demonstrated CI to be safe and hemostatically effective for all indications mentioned above, including the most demanding surgical procedures [1,2,[4][5][6][7]20,[34][35][36][37][38]. Most recently Takedani [37], Rahmé et al [38], and Chevalier et al [39] reported on successful use of CI in 28, 20, and 72 total knee replacements, respectively. A prospective controlled study comparing CI and BI for major surgery using protocols that were similar regarding the surgical technique and postoperative target minimum levels demonstrated that efficacy and safety were better with CI than with BI in terms of minimum factor levels achieved, blood loss (as measured by a decrease in hemoglobin level), blood transfusion requirements, and bleeding complications ( [24].…”