Total joint replacement in patients with inhibitors

Solimeno, Luigi Piero; Perfetto, O. S.; Pasta, Gianluigi; Santagostino, Elena

doi:10.1111/j.1365-2516.2006.01267.x

Cited by 31 publications

(42 citation statements)

References 23 publications

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“…They found that most bleeding complications could be resolved by increasing the rFVIIa dose or administering an extra dose and concluded that the optimal initial rFVIIa bolus dose for orthopedic surgery may be higher than 90 μg/kg. Furthermore, in the major orthopedic interventions reported by Solimeno et al23 and Rodriguez-Merchan et al,24 bleeding complications were only observed in patients receiving the dose of 90 μg/kg rFVIIa. Based on these data, a minimum initial dose of 120 μg/kg rFVIIa, followed by a similar or 90 μg/kg dose every 2 hours, was suggested for patients in the BI group 22…”

Section: Discussionmentioning

confidence: 92%

Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders

Johansson

Ostrowski²

2010

DDDT

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Background:Recombinant activated factor VII (rFVIIa, NovoSeven®) was introduced in 1996 for the treatment of hemophilic patients with antibodies against coagulation factor VIII or IX.Objective:To review the evidence supporting the use of rFVIIa for the treatment of patients with congenital bleeding disorders.Patients and methods:English-language databases were searched in September 2009 for reports of randomized controlled trials (RCTs) evaluating the ability of rFVIIa to restore hemostasis in patients with congenital bleeding disorders.Results:Eight RCTs involving 256 hemophilic patients with antibodies against coagulation factors, also known as inhibitors, were identified. The evidence supporting the use of rFVIIa in these patients was weak with regard to dose, clinical setting, mode of administration, efficacy, and adverse events, given the limited sample size of each RCT and the heterogeneity of the studies.Conclusion:The authors suggest that rFVIIa therapy in hemophilic patients with inhibitors should be based on the individual’s ability to generate thrombin and form a clot, and not on the patient’s weight alone. Therefore, assays for thrombin generation, such as whole-blood thromboelastography, have the potential to significantly improve the treatment of these patients.

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Section: Discussionmentioning

confidence: 92%

Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders

Johansson

Ostrowski²

2010

DDDT

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“…Due to an excellent response of our patient to a 90 µg/kg dose of rFVIIa, we did not consider the initially recommended dose of 270 µg/kg (9). Solimeno et al reported that a high responder patient had a 1 BU/ml antibody titer at the time of surgery; a high dose of factor VIII (52000 U) was used for the first five days and on the fifth day after surgery, rFVIIa was administered for two days (6). In our case, the patient’s inhibitor titer was below 1 BU/ml before surgery, and we controlled his bleeding during and after surgery with a high dose of FVIII.…”

Section: Discussionmentioning

confidence: 99%

“…Such cases represent a major therapeutic challenge to clinicians (5). Arthroplastic surgery in hemophilic patients having such inhibitors remains a rare, expensive, and difficult surgery, whose management represents a significant challenge (6). Since 1988, recombinant activated factor VII (rFVIIa) have been indicated for use in surgical prophylaxis, as well as for the treatment of bleeding episodes, in patients with hemophilia and high-responding inhibitors.…”

Section: Introductionmentioning

confidence: 99%

Successful Management of Total Knee Replacement in a High Responder Hemophilia Patient With a History of Inhibitor

Dolatkhah¹,

Bazavar²,

Poureisa³

et al. 2013

Iran Red Crescent Med J

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The development of inhibitors against administered clotting factors may render replacement therapy ineffective for some hemophilia patients. Such patients are therefore at the highest risk of developing arthropathy. Elective orthopedic surgery (EOS) in hemophilic patients having such inhibitors remains a rare, expensive, and difficult surgery, whose management represents a significant challenge. We report the case of a 35-year-old man with a severe form of hemophilia A (factor VIII < 1%), who was suffering from repetitive spontaneous hemarthrosis, especially in his knee joints that had consequently become more susceptible to bleeding. The patient had a history of high levels of factor VIII inhibitor (> 5.0 Bethesda Unit [BU]/ml) as shown by the factor VIII inhibitor assay; therefore, we began treatment with factor VIIa for his mild-to-moderate bleeding (90 µg/kg intravenous bolus injections). The interval between injections varied with the severity of the hemorrhage in each bleeding episode. The inhibitor level reduced to 3.1 BU/ml after three months, to 1.6 BU/ml after six months, and disappeared completely after one year of treatment. We administered factor VIII at a dose of 50 IU/kg every eight hours during the first three post-operative days, then continued administration with a dose of 40 IU/kg every 12 hours for another four days, and observed a very good response to treatment with no bleeding. Recombinant activated factor VII (rFVIIa) is not an inhibitor-removal strategy, but an inhibitor-bypassing product. However, in our patient, the treatment of mild-to-moderate bleeding with short-term use of rFVIIa and no exposure to factor VIII caused a gradual reduction in the inhibitor level over a period of 1 year.

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“…They found that most bleeding complications could be resolved by increasing the rFVIIa dose or administering an extra dose and concluded that the optimal initial rFVIIa bolus dose for orthopedic surgery may be higher than 90 µg/kg. Furthermore, in the major orthopedic interventions reported by Solimeno et al 23 and Rodriguez-Merchan et al, 24 bleeding complications were only observed in patients receiving the dose of 90 µg/ kg rFVIIa. Based on these data, a minimum initial dose of 120 µg/kg rFVIIa, followed by a similar or 90 µg/kg dose every 2 hours, was suggested for patients in the BI group.…”

Section: Dose Evaluationmentioning

confidence: 99%

“…15 The considerable heterogeneity in the assessment of hemostatic efficacy and in sampling time points is in agreement with reports from nonrandomized studies. 10,[22][23][24][25][32][33][34][37][38][39] Obviously, this constitutes a significant problem for the interpretation and comparison of results from the studies of patients with hemophilia. Thus, data interpretation and the comparison of efficacy in the future studies on patients with hemophilia would be improved if efficacy parameters were standardized.…”

Section: Treatment Efficacy Evaluationmentioning

confidence: 99%

Evidence Supporting the Use of Recombinant Activated Factor VII in Congenital Bleeding Disorders

Johansson¹,

Ostrowski²

2011

European Oncology &Amp; Haematology

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Recombinant activated factor VII ([rFVIIa] NovoSeven) was introduced in 1996 for the treatment of haemophilia patients with inhibitors (HPIs) to factor VIII or IX. This article reviews the evidence for the use of rFVIIa in congenital bleeding disorders. English-language databases were searched in September 2009 for reports of randomised controlled trials (RCTs) evaluating the effect of rFVIIa on haemostasis in congenital bleeding disorders. Eight RCTs comprising 256 HPIs were identified. The evidence for the use of rFVIIa in HPIs in terms of dose, clinical setting, modes of administration, efficacy and adverse events was weak, given the limited number of patients included and the heterogeneity of the RCTs. Overall, the haemostatic efficacy of rFVIIa varied from 25 to 100% in the studies reviewed; <1% of the patients receiving rFVIIa developed a thromboembolic adverse event. The authors suggest that the addition FVIIa therapy to HPIs should be based on the patients ability to generate thrombin and form a clot, rather than being based on weight alone. Assays reflecting thrombin generation, such as whole-blood thrombelastography, have the potential to significantly improve the treatment of these patients.

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Total joint replacement in patients with inhibitors

Cited by 31 publications

References 23 publications

Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders

Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders

Successful Management of Total Knee Replacement in a High Responder Hemophilia Patient With a History of Inhibitor

Evidence Supporting the Use of Recombinant Activated Factor VII in Congenital Bleeding Disorders

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