MonoFIX‐VF, a new mono‐component factor IX concentrate: a single‐centre continuous‐infusion study

Evans, Gillian; Collett, Merrill; Came, Neil; Lloyd, John Uri; Powell, Leslie; Street, Alison

doi:10.1046/j.1365-2516.2002.00663.x

Cited by 4 publications

(3 citation statements)

References 15 publications

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“…In 1992, a multicenter study by Goldsmith, et al [8], examined the use of AlphaNine Ò , a plasma-derived FIX concentrate, in 13 patients and found no adverse events and adequate haemostasis after surgery. Other studies have found similar results from both plasma-derived [9][10][11] and recombinant products [2,12]. Zakarija has reported a clear preference for plasma-derived factor in surgery because in her view, they provide more reliable control over factor levels and better control of bleeding [13].…”

Section: Introductionmentioning

confidence: 71%

Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine^® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Quon

Logan

2010

Haemophilia

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While coagulation factor replacement is essential in surgical intervention in haemophilia B patients, few studies are available on the safety and efficacy of plasma-derived factor IX (FIX) for haemostasis during surgery. This retrospective study examined outcomes in these patients. A total of 20 patients who underwent 29 surgical procedures at the Hemophilia Treatment Center at Orthopaedic Hospital in Los Angeles, California, were identified and their inpatient charts were reviewed and abstracted. Outcomes included pre- and postoperative FIX dosing, recovery of FIX, blood loss, use of blood products, safety and haemostatic response. Identified patients had mild (10%), moderate (15%) or severe (75%) haemophilia B, and average age at surgery was 48.5 years. All surgical procedures were major (orthopaedic 89.7%; abdominal 10.3%), all were completed under general anaesthesia, and average time in surgery was 3.25 h. Average hospital length of stay was 11.0 days [standard deviation (SD) = 8.5] and all patients were discharged home. All patients were treated with AlphaNine® SD at an average dose of 254.9 IU kg(-1) (SD = 65.4) on the day of surgery and the dose was adjusted over the course of hospital stay. Mean perioperative blood loss was 255.5 mL (SD = 283.1) and blood replacement was required in only two surgeries (6.9%). FIX recovery analysis performed preoperatively related well to FIX levels obtained. Identified patients had little blood loss perioperatively and had no bleeding related complications. Plasma-derived FIX pre- and postoperatively appeared to be a safe and effective treatment in haemophilia B patients undergoing surgery.

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Section: Introductionmentioning

confidence: 71%

Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine^® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Quon

Logan

2010

Haemophilia

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“…Literature review. Thirty‐five clinical studies were reviewed [10–44] (Table 1). Eight studies were considered to have reached level of evidence 2 and 27 studies up to level 3.…”

Section: Resultsmentioning

confidence: 99%

Replacement therapy for invasive procedures in patients with haemophilia: literature review, European survey and recommendations

et al. 2009

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Summary. Although most surgical and invasive procedures can be performed safely in patients with haemophilia, the optimal level and duration of replacement therapy required to prevent bleeding complications have not been established conclusively. For providing more insight into optimal therapy during invasive procedures, a literature review of surgical procedures in patients with haemophilia was conducted. Concomitantly, current practice was surveyed in 26 European Haemophilia Comprehensive Care Centres, representing 15 different countries. The review identified 110 original papers published between 1965 and 2007. Of these, only two studies were randomized controlled trials. Target levels and the duration of replacement therapy in the published studies were as follows. For major orthopaedic surgery: preoperative targets were 80–90%; postoperative targets showed a high degree of variation, with trough levels ranging from 20% to 80%, duration 10–14 days; for liver biopsy, 70–100%, 1–7 days; tonsillectomy: 90–100%, 5–11 days; indwelling venous access device insertion: 100%, 3–10 days; circumcision: 50–60%, 2–4 days; dental surgery: 30–50%, single treatment. With the exception of dental surgery, current practice in Europe, as assessed by the survey, was largely in agreement with published data. In conclusion, this study provides both a comprehensive review and a large survey of replacement therapy in patients with haemophilia undergoing invasive procedures; these data have informed the consensus practical treatment recommendations made in this paper. This study highlights the need for better‐designed studies in order to better define minimal haemostatic levels of replacement therapy and optimal treatment duration.

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“…These studies comprised a total of 50 patients and 59 continuous infusion treatments (55 for major surgery) and provided evidence of an excellent hemostatic effect [35][36][37][38]46]. The initial factor IX (FIX) bolus of 12.4-155 IU was followed by infusion rates ranging between 1.7 and 8.6 IU/kg/h (median 3.9 IU/ kg/h) and aimed at maintenance FIX levels of more than 0.9 IU/ml in all studies but one that targeted FIX levels of 0.5-1.0 IU/ml.…”

Section: Continuous Infusion Of Factor IXmentioning

confidence: 99%

Continuous infusion of coagulation factors: current opinion

Bátorová¹,

Martinowitz

2006

Current Opinion in Hematology

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Continuous infusion has been shown to be a safe and cost-effective mode of replacement for treatment of hemophilia. The lack of evidence-based information on the hemostatic levels to be maintained in specific clinical situations, and recent concerns regarding the development of inhibitors, particularly in patients with mild hemophilia treated with continuous infusion, need to be addressed by prospective, randomized studies that compare traditional intermittent injections and the continuous infusion mode of factor replacement.

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MonoFIX‐VF, a new mono‐component factor IX concentrate: a single‐centre continuous‐infusion study

Cited by 4 publications

References 15 publications

Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine^® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine^® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Replacement therapy for invasive procedures in patients with haemophilia: literature review, European survey and recommendations

Continuous infusion of coagulation factors: current opinion

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MonoFIX‐VF, a new mono‐component factor IX concentrate: a single‐centre continuous‐infusion study

Cited by 4 publications

References 15 publications

Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Replacement therapy for invasive procedures in patients with haemophilia: literature review, European survey and recommendations

Continuous infusion of coagulation factors: current opinion

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Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine^® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis

Safety and efficacy of plasma‐derived coagulation factor IX concentrate (AlphaNine^® SD) in patients with haemophilia B undergoing surgical intervention: a single institution retrospective analysis