Factor VIII: C (FVIII: C) Recovery and Half-Life After Infusion of Steam-Treated High Purity Factor VIII Concentrate in Severe Hemophilia A - Comparison of One-Stage Assay, Two-Stage Assay and a Chromogenic Substrate Assay

Hellstern, Peter; Kiehl, R.; Miyashita, C.; Schwerdt, Holger; Blohn, G. von; Köhler, Michael; Büttner, Maike; Wenzel, E.

doi:10.1055/s-0038-1661682

Cited by 30 publications

(17 citation statements)

References 16 publications

(21 reference statements)

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“…Our mean V dss of 0.052 L kg −1 was comparable with the lower end of values reported in the literature (0.052–0.082 L kg −1 ) [ 8, 18]. The mean t 1/2 calculated (12.7 h) lies in the 10–19 h range of values reported [ 19–21].…”

Section: Discussionsupporting

confidence: 89%

Continuous infusion of intermediate‐purity factor VIII in haemophilia A patients undergoing elective surgery

et al. 1999

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An open, non-randomized trial of continuous infusion therapy was conducted involving five patients with severe haemophilia A who required factor VIII (FVIII) prophylaxis for elective surgery. This was preceded by a 24-h preoperative pharmacokinetic study to characterize the pharmacokinetic parameters of each individual patient following a bolus dose of the intermediate-purity product. A retrospective matched control group was identified to allow for comparisons of FVIII usage between bolus and continuous infusion administration. A loading dose of FVIII was administered preoperatively, and the continuous infusion was started at the end of surgery and continued for 5 days. The patients' FVIII levels, vital signs, and infusion sites were monitored on a daily basis. The clearance was re-calculated on a daily basis using the FVIII activity of that day to adjust the infusion rate to achieve the desired FVIII level. The mean (CV%) pharmacokinetic parameters estimated preoperatively by noncompartmental analysis were: clearance 3.2 mL kg-1 h-1 (35.5%), volume of distribution 52.1 mL kg-1 (40.2%), mean residence time 17.4 h (23.3%), and half-life 12.7 h (23.6%). A progressive decrease in the clearance of FVIII from a mean of 3.1 mL kg-1 h-1 to 2.0 mL kg-1 h-1 (P = 0.125) over the first 5 days was observed. A therapeutically acceptable level of FVIII was systematically achieved, with the only complication being frequent thrombophlebitis. On average the patients used 19% less FVIII when compared with matched historical controls (P = 0.25). This method was found to be safe and effective in haemophilia A patients undergoing elective surgery procedures.

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Section: Discussionsupporting

confidence: 89%

Continuous infusion of intermediate‐purity factor VIII in haemophilia A patients undergoing elective surgery

et al. 1999

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“…2b). Wide variations between the results obtained by chromogenic and onestage FVIII clotting assays were described previously [5,13,26]. These variations are supposed to be caused by interlaboratory variations and by the use of different standards.…”

Section: Discussionmentioning

confidence: 88%

Analysis of expression kinetics and activity of a new B-domain truncated and full-length FVIII protein in three different cell lines

Haack

Schmitt

Poller

et al. 1999

Annals of Hematology

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Transient expression of full-length wild-type (wt) and a new B-domain truncated (deltaB) FVIII has been investigated in three eukaryotic cell lines (HEK-293, COS, CHO). When expressed in CHO cells, both FVIII proteins reached the same peak antigen levels, whereas in HEK-293 and COS cells those of FVIII/deltaB were up to sixfold those of FVIII/wt. Investigation of specific activity of the recombinant FVIII proteins using a chromogenic and a one-stage assay in addition to the FVIII-antigen ELISA revealed large variations: In HEK-293 cells specific activity of FVIII/deltaB measured with both assays was higher than that of FVIII/wt. In COS cells specific activity of both FVIII proteins was higher measured in the one-stage assay than in the chromogenic assay. In CHO cells both FVIII proteins had similar specific activity in each assay. In summary, expression kinetics and specific activity of conditioned medium vary depending on cell type used.

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“…Several studies have compared CSA with OSA in FVIII determinations . However, most investigated response to FVIII concentrates in haemophilia patients or FVIII concentrate‐spiked samples.…”

Section: Discussionmentioning

confidence: 99%

Performance evaluation of Revohem^™ FVIII chromogenic and Revohem^™ FIX chromogenic in the CS‐5100 autoanalyser

Suzuki

Kanematsu

et al. 2019

Int J Lab Hematology

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Introduction Chromogenic substrate assay (CSA) reagents Revohem™ FVIII and Revohem™ FIX are now available as in vitro diagnostic reagents for autoanalysers in Japan. In this study, we evaluated the performance of these reagents in the CS‐5100 automated coagulation analyser. Methods We assessed within‐run and between‐day imprecision, on‐board stability and frozen‐storage stability of Revohem FVIII and FIX. Sensitivity to lupus anticoagulant (LA) was examined using LA‐positive patient plasma. Correlations were analysed using plasma samples from normal individuals and patients with haemophilia A (HA) or B (HB) or von Willebrand disease (VWD). Results Imprecision was <2% for Revohem FVIII and <6.5% for Revohem FIX. On‐board storage of Revohem FVIII resulted in a <10% decrease in FVIII levels from baseline at 24 hours, whereas Revohem FIX showed a >10% decrease at 8 hours. Revohem FVIII showed good stability while frozen for 22 days. Although Revohem FIX showed degradation due to freeze‐thawing, a new calibration improved stability up to 22 days. Interference from LA was not observed with Revohem FVIII or FIX. The FVIII CSA‐CSA correlation was excellent in normal (r = 0.9924), HA (r = 0.9945) and VWD (r = 0.9914). The FVIII CSA‐OSA correlation was good in normal (r = 0.8468) and excellent in HA (r = 0.975) and VWD (r = 0.9936). The FIX CSA‐OSA correlation was fair in normal (r = 0.4791) and excellent in HB (r = 0.9501). Conclusion Revohem FVIII and FIX both showed excellent performance in the CS‐5100 analyser. These reagents could be useful in routine laboratory testing for diagnosing and treating haemophilia.

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Factor VIII: C (FVIII: C) Recovery and Half-Life After Infusion of Steam-Treated High Purity Factor VIII Concentrate in Severe Hemophilia A - Comparison of One-Stage Assay, Two-Stage Assay and a Chromogenic Substrate Assay

Cited by 30 publications

References 16 publications

Continuous infusion of intermediate‐purity factor VIII in haemophilia A patients undergoing elective surgery

Continuous infusion of intermediate‐purity factor VIII in haemophilia A patients undergoing elective surgery

Analysis of expression kinetics and activity of a new B-domain truncated and full-length FVIII protein in three different cell lines

Performance evaluation of Revohem^™ FVIII chromogenic and Revohem^™ FIX chromogenic in the CS‐5100 autoanalyser

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Factor VIII: C (FVIII: C) Recovery and Half-Life After Infusion of Steam-Treated High Purity Factor VIII Concentrate in Severe Hemophilia A - Comparison of One-Stage Assay, Two-Stage Assay and a Chromogenic Substrate Assay

Cited by 30 publications

References 16 publications

Continuous infusion of intermediate‐purity factor VIII in haemophilia A patients undergoing elective surgery

Continuous infusion of intermediate‐purity factor VIII in haemophilia A patients undergoing elective surgery

Analysis of expression kinetics and activity of a new B-domain truncated and full-length FVIII protein in three different cell lines

Performance evaluation of Revohem™ FVIII chromogenic and Revohem™ FIX chromogenic in the CS‐5100 autoanalyser

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Product

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Performance evaluation of Revohem^™ FVIII chromogenic and Revohem^™ FIX chromogenic in the CS‐5100 autoanalyser