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Auerswald G.,Center for Thrombosis and Haemostasis | Bade A.,Center for Thrombosis and Haemostasis | Johne J.,Center for Thrombosis and Haemostasis | Haubold K.,Center for Thrombosis and Haemostasis | And 3 more authors.
Thrombosis Research | Year: 2014

Introduction: Inhibitor development in severe haemophilia A patients is currently the most serious complication of factor VIII (FVIII) treatment. Although continuous infusion (CI) of FVIII concentrate during surgical procedures in haemophilia A patients has been shown to be beneficial, some publications suggest that CI increases the risk of inhibitor generation. We conducted a prospective subgroup analysis to investigate if CI of the high-purity, pasteurized, plasma-derived FVIII concentrate Beriate® P during surgery increases the risk of inhibitor formation. Materials and methods: Patients with severe haemophilia A (FVIII:C <1%) were included if they presented with a negative history of previous inhibitors, had ≥50 exposure days, and had been scheduled for a planned surgical procedure. A bolus infusion (30-50 IU/kg body weight) of Beriate® P was administered intravenously and followed by CI at a rate of 3-4 IU/kg body weight/hour. Dose adjustments were subsequently made based on daily measurements of plasma FVIII activity. Results: Five patients (aged 8-34 years) with severe haemophilia A were included. The surgical procedures ranged from teeth extraction to internal fixation of a fracture. There was no inhibitor generation with CI of Beriate® P in patients undergoing surgery, and we did not observe any complications due to re-bleeding or virus transmission. Conclusion: Beriate® P was efficacious, safe, and well tolerated during CI. © 2013 Published by Elsevier Ltd.


Monahan P.E.,University of North Carolina at Chapel Hill | Doria A.S.,University of Toronto | Ljung R.,Center for Thrombosis and Haemostasis | Jimenez-Yuste V.,Hospital Universitario La Paz
Haemophilia | Year: 2012

Progressive joint destruction resulting from intra-articular bleeding is the major morbidity affecting patients with haemophilia (PWH), particularly those with inhibitors. Advances in understanding the detrimental processes set in motion by the exposure of joints to bleeding have shaped current management methods. However, to achieve optimal joint health in PWH, in addition to achieving haemostasis at the bleeding vessel, it may be appropriate to explore experimentally other conceptual frameworks. These include the possibilities that markers might help to identify individuals at the risk of more rapid joint deterioration, that clotting factors may have additional local action within tissues, and that outcomes might be improved with therapies that directly address wound healing and inflammation. Joint assessment tools are important. Conventional radiography is frequently used, but given the possibility of subclinical joint bleeds, accurate non-invasive imaging tools are required to detect soft tissue and cartilage changes. Magnetic resonance imaging and ultrasonography can prove valuable here. New imaging techniques should help to increase understanding of the biological basis of early events in haemophilic arthropathy. The optimal way to measure outcomes in haemophilia is to use several methods - in addition to imaging methods, a 360° approach will use physical, functional and quality-of-life instruments. In PWH, inhibitor development complicates treatment of joint bleeds and increases the risk of developing arthropathy. A new therapeutic approach for joint bleeds in inhibitor patients divides treatment into two phases: bleed control, with bypassing agent therapy until bleeding has definitely ceased, followed by regular dosing to prevent rebleeds until synovial recovery is complete. © 2012 Blackwell Publishing Ltd.


Robinson S.,University of Southern Denmark | Zincuk A.,University of Southern Denmark | Strom T.,University of Southern Denmark | Larsen T.B.,Center for Thrombosis and Haemostasis | And 2 more authors.
Critical Care | Year: 2010

Introduction: Intensive care unit (ICU) patients are predisposed to thromboembolism. Routine prophylactic anticoagulation is widely recommended. Low-molecular-weight heparins, such as enoxaparin, are increasingly used because of predictable pharmacokinetics. This study aims to determine the subcutaneous (SC) dose of enoxaparin that would give the best anti-factor Xa levels in ICU patients.Methods: The 72 patients admitted to a mixed ICU at Odense University Hospital (OUH) in Denmark were randomised into four groups to receive 40, 50, 60, or 70 mg SC enoxaparin for a period of 24 hours. Anti-factor Xa activity (aFXa) was measured before, and at 4, 12, and 24 hours after administration. An AFXa level between 0.1 to 0.3 IU/ml was considered evidence of effective antithrombotic activity.Results: Median peak (4 hours after administration), aFXa levels increased significantly with an increase in enoxaparin dose, from 0.13 IU/ml at 40 mg, to 0.14 IU/ml at 50 mg, 0.27 IU/ml at 60 mg, and 0.29 IU/ml at 70 mg (P = 0.002). At 12 hours after administration, median aFXa levels were still within therapeutic range for those patients who received 60 mg (P = 0.02).Conclusions: Our study confirmed that a standard dose of 40 mg enoxaparin yielded subtherapeutic levels of aFXa in critically ill patients. Higher doses resulted in better peak aFXa levels, with a ceiling effect observed at 60 mg. The present study seems to suggest inadequate dosage as one of the possible mechanisms for the higher failure rate of enoxaparin in ICU patients.Trial Registration: ISRCTN03037804. © 2010 Robinson et al.; licensee BioMed Central Ltd.


PubMed | Center for Thrombosis and Haemostasis
Type: | Journal: Thrombosis research | Year: 2014

Inhibitor development in severe haemophilia A patients is currently the most serious complication of factor VIII (FVIII) treatment. Although continuous infusion (CI) of FVIII concentrate during surgical procedures in haemophilia A patients has been shown to be beneficial, some publications suggest that CI increases the risk of inhibitor generation. We conducted a prospective subgroup analysis to investigate if CI of the high-purity, pasteurized, plasma-derived FVIII concentrate Beriate() P during surgery increases the risk of inhibitor formation.Patients with severe haemophilia A (FVIII:C <1%) were included if they presented with a negative history of previous inhibitors, had 50 exposure days, and had been scheduled for a planned surgical procedure. A bolus infusion (30-50 IU/kg body weight) of Beriate() P was administered intravenously and followed by CI at a rate of 3-4 IU/kg body weight/hour. Dose adjustments were subsequently made based on daily measurements of plasma FVIII activity.Five patients (aged 8-34 years) with severe haemophilia A were included. The surgical procedures ranged from teeth extraction to internal fixation of a fracture. There was no inhibitor generation with CI of Beriate() P in patients undergoing surgery, and we did not observe any complications due to re-bleeding or virus transmission.Beriate() P was efficacious, safe, and well tolerated during CI.

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