Clinical Experience With a Swedish Factor Ix Concentrate

Nilsson, Inga Marie; Ahlberg, A; Björlin, G

doi:10.1111/j.0954-6820.1971.tb07427.x

Cited by 20 publications

(8 citation statements)

References 9 publications

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“…The characteristics of these concentrates are given in Table 1. Both PCCs were given at a dose of 50 IU kg À1 , which was selected on the basis of data from preclinical models [7], the results of a previous clinical study [5], and the fact that this dosage regimen falls within the PCC dose range recommended for the management of moderate bleeding [8][9][10][11]. [12].…”

Section: Study Medicationmentioning

confidence: 99%

Comparison of three‐factor and four‐factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers

Levi

Moore

Castillejos

et al. 2014

Journal of Thrombosis and Haemostasis

188

158

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Comparison of three-factor and four-factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers. J Thromb Haemost 2014; 12: 1428-36.See also Makris M. Prothrombin complex concentrate for non-vitamin K oral anticoagulant reversal: good enough for now? This issue, pp 1425-7.Summary. Background: Four-factor prothrombin complex concentrates (PCCs), which contain factor II, FVII, FIX, and FX, have shown the potential to reverse the anticoagulant effect of rivaroxaban in healthy volunteers. The purpose of this study was to determine whether a threefactor PCC, which contains little FVII, has a similar effect. Methods and results:We performed an open-label, single-center, parallel-group study comparing the effect of a three-factor PCC (Profilnine SD) with that of a fourfactor PCC (Beriplex P/N) on the pharmacodynamics of rivaroxaban in 35 healthy volunteers. After receiving 4 days of rivaroxaban 20 mg twice daily to obtain supratherapeutic steady-state concentrations, volunteers were randomized to receive a single 50 IU kg À1 bolus dose of four-factor PCC, three-factor PCC or saline 4 h after the morning dose of rivaroxaban on day 5, and the effects of these interventions on prothrombin time and thrombin generation were determined. Within 30 min, four-factor PCC reduced mean prothrombin time by 2.5-3.5 s, whereas three-factor PCC produced only a 0.6-1.0-s reduction. In contrast, three-factor PCC reversed rivaroxaban-induced changes in thrombin generation more than four-factor PCC. Conclusions: This study demonstrates the potential of both three-factor and four-factor PCCs to at least partially reverse the anticoagulant effects of rivaroxaban in healthy adults. The discrepant effects of the PCC preparations may reflect differences in the procoagulant components present in each.

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Section: Study Medicationmentioning

confidence: 99%

Comparison of three‐factor and four‐factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers

Levi

Moore

Castillejos

et al. 2014

Journal of Thrombosis and Haemostasis

188

158

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“…Since the in vivo yield of factor IX infusion is only 30-60% of the in vitro activity, and since the half-life of factor IX is approximately 20 hours, [25,32,33] factor IX was given in higher initial doses, but with a longer interval between the doses, compared to factor VIII. In major surgery in patients with severe hemophilia B, the initial dose was usually 60-70 units/kg body weight and 30-40 units 8-10 hours later.…”

Section: Hemophilia Bmentioning

confidence: 99%

Surgery of hemophiliacs—20 years' experience

et al. 1977

Self Cite

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Seventy-seven hemophilic patients of type A or type B were subjected to a total of 108 major surgical procedures mainly in the field of general surgery, orthopedic surgery, or neurosurgery. The principles for the substitution therapy in the different types of procedures and different types of hemophilic diseases are described, as well as the indications for surgery and the surgical technique. The importance of prolonged substitution therapy postoperatively to avoid late hematoma, particularly in patients with severe hemophilia undergoing major surgery, is stressed. With this type of management there has been no increased intraoperative hemorrhage, and very few cases of late hematoma formation. By combining the substitution therapy with immunosuppression, it has been possible to operate also on patients with inhibitors against factor VIII or IX. The rate of complications, particularly the incidence of hepatitis, has been low with the type of substitution given in this series of patients. It is concluded that major surgery can be carried out even in severe hemophilia without significantly increased risk. The handling of the substitution therapy, and the surgical judgment and technique, offers however, special problems, necessitating centralization of elective cases.

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“…The early milestones of treatment of hemophilia with replacement of the missing coagulation factor were when the so-called Fraction I-0 containing FVIII was isolated from plasma in the late 1950s [ 3 ], and the finding and use of cryoprecipitate as a source of FVIII in the early 1960s [ 4 ]. FIX concentrate from plasma became available soon afterwards [ 5 ], but almost 10 years later was more widely used in clinical practice [ 6 ]. These first concentrates were not pure and contained many other proteins in addition.…”

Section: The Development Of Factor Replacement Therapymentioning

confidence: 99%

Prevention and Management of Bleeding Episodes in Children with Hemophilia

Ljung

2018

Pediatr Drugs

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Regular prophylactic treatment with factor VIII (FVIII) and factor IX (FIX) concentrates in hemophilia A and B, respectively, is introduced in early infancy and has resulted in dramatic improvement of the conditions. Recombinant FVIII and FIX concentrates have been available for > 25 years and have been modified and refined through the years; however, unfortunately frequent intravenous administrations are still necessary. The half-lives of these products have now been extended (EHL) by fusion with albumin, the Fc-portion of IgG, or by being PEGylated. This has been very successful for EHL-FIX, with 3–5 times longer half-life, and to a lesser degree for EHL-FVIII with a half-life extension of only 1.5 times the conventional products. New treatment principles using FVIII mimetics or monoclonal antibodies that rebalance the pro- and anti-coagulation system by interfering with production of anti-thrombin or tissue factor pathway inhibitor have the benefits of long-lasting activity, subcutaneous administration, and being useful in patients both with and without neutralizing antibodies. As the ultimate treatment, recent progress has also been made with gene therapy of both hemophilia A and B.

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Clinical Experience With a Swedish Factor Ix Concentrate

Cited by 20 publications

References 9 publications

Comparison of three‐factor and four‐factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers

Comparison of three‐factor and four‐factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers

Surgery of hemophiliacs—20 years' experience

Prevention and Management of Bleeding Episodes in Children with Hemophilia

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