Pathogen safety of long-term treatments for bleeding disorders: still relevant to current practice

Minno, G. Di; Canaro, Mariana; Ironside, James W.; Navarro, David; Perno, Carlo Federico; Tiede, Andreas; Gürtler, Lutz

doi:10.3324/haematol.2013.084145

Cited by 18 publications

(21 citation statements)

References 18 publications

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“…However, plasma-derived products are limited by plasma donor availability, and the theoretical risk of pathogen transmission cannot be excluded despite viral screening and attenuation measures that have been instituted to minimize such concerns. 14,15 Plasma-derived VWF/FVIII products also vary in composition depending on the source plasma and the manufacturing process. [16][17][18][19] This variability could lead to excessive FVIII levels in VWD patients, with inherent risk of venous thromboembolism.…”

Section: Introductionmentioning

confidence: 99%

Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease

Gill

Castaman

Windyga

et al. 2015

Blood

129

134

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Section: Introductionmentioning

confidence: 99%

Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease

Gill

Castaman

Windyga

et al. 2015

Blood

129

134

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show abstract

“…Babies with no family history of haemophilia were more likely to receive blood and blood bank products. Awareness of manifestations of haemophilia in the babies coupled with early involvement/consultation of HTCs may result in the institution of appropriate therapy including prophylaxis with pathogen-safe plasma-derived or recombinant concentrates and prevent or reduce risk of exposure to blood and blood bank products [24]. …”

Section: Discussionmentioning

confidence: 99%

Complications of haemophilia in babies (first two years of life): a report from the Centers for Disease Control and Prevention Universal Data Collection System

et al. 2016

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Aim To describe the prevalence and complications in babies ≤2 years with haemophilia. Methods We used a standardized collection tool to obtain consented data on eligible babies aged ≤2 years with haemophilia enrolled in the Centers for Disease Control and Prevention Universal Data Collection System surveillance project at US Hemophilia Treatment Centers (HTCs). Results Of 547 babies, 82% had haemophilia A, and 70% were diagnosed within one month of birth. Diagnosis was prompted by known maternal carrier status (40%), positive family history (23%), bleeding (35%) and unknown 2%; 81% bled during the first two years. The most common events were bleeding (circumcision, soft tissue, oral bleeding) and head injury. There were 46 episodes of intracranial haemorrhage (ICH) in 37 babies (7%): 18 spontaneous, 14 delivery related, 11 traumatic, 2 procedure related and 1 unknown cause. Of the 176 central venous access devices (CVADs) in 148 (27%) babies, there were 137 ports, 22 surgically inserted central catheters and 20 peripherally inserted central catheters. Ports had the lowest complication rates. Inhibitors occurred in 109 (20%) babies who experienced higher rates of ICH (14% vs. 5%; P = 0.002), CVAD placement (61% vs. 19%; P < 0.001) and CVAD complications (44% vs. 26%; P < 0.001). The most common replacement therapy was recombinant clotting factor concentrates. Conclusion Bleeding events in haemophilic babies ≤2 years were common; no detectable difference in the rates of ICH by the mode of delivery was noted. Neonatal factor exposure did not affect the inhibitor rates. Minor head trauma, soft tissue and oropharyngeal bleeding were the leading indications for treatment.

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“…Since recombinant clotting factors are not derived from blood or plasma, they present a minimal risk of pathogen transmission (particularly third generation factors, which have no contact with blood/ plasma-derived components whatsoever) and can therefore be considered safer than using plasma-derived clotting factor concentrates [11]. However, there has been concern that the use of recombinant clotting factors may be associated with an increased rate of inhibitor formation in patients who regularly receive these products [12]; this is another factor that may influence the overall clinical assessment of patient risk.…”

Section: Abstract a R T I C L E I N F Omentioning

confidence: 99%

“…e l s e v i e r . c o m / l o c a t e / b l r e which may contain infectious agents) is effective in reducing the rate of pathogen transmission, but may result in the unnecessary wastage of blood/plasma-derived products.Since recombinant clotting factors are not derived from blood or plasma, they present a minimal risk of pathogen transmission (particularly third generation factors, which have no contact with blood/ plasma-derived components whatsoever) and can therefore be considered safer than using plasma-derived clotting factor concentrates [11]. However, there has been concern that the use of recombinant clotting factors may be associated with an increased rate of inhibitor formation in patients who regularly receive these products [12]; this is another factor that may influence the overall clinical assessment of patient risk.Recombinant clotting factors are available for the treatment of haemophilia A (FVIII) and B (FIX) and factor VII/XIII deficiency, while plasma-derived concentrates are available for most other clotting factors (including von Willebrand factor, fibrinogen and the vitamin K dependent clotting factors).…”

mentioning

confidence: 99%

Current concepts in the prevention of pathogen transmission via blood/plasma-derived products for bleeding disorders

et al. 2016

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The pathogen safety of blood/plasma-derived products has historically been a subject of significant concern to the medical community. Measures such as donor selection and blood screening have contributed to increase the safety of these products, but pathogen transmission does still occur. Reasons for this include lack of sensitivity/specificity of current screening methods, lack of reliable screening tests for some pathogens (e.g. prions) and the fact that many potentially harmful infectious agents are not routinely screened for. Methods for the purification/inactivation of blood/plasma-derived products have been developed in order to further reduce the residual risk, but low concentrations of pathogens do not necessarily imply a low level of risk for the patient and so the overall challenge of minimising risk remains. This review aims to discuss the variable level of pathogenic risk and describes the current screening methods used to prevent/detect the presence of pathogens in blood/plasma-derived products

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Pathogen safety of long-term treatments for bleeding disorders: still relevant to current practice

Cited by 18 publications

References 18 publications

Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease

Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease

Complications of haemophilia in babies (first two years of life): a report from the Centers for Disease Control and Prevention Universal Data Collection System

Current concepts in the prevention of pathogen transmission via blood/plasma-derived products for bleeding disorders

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