Recombinant factor VIIa in continuous infusion during central line insertion in a child with factor VIII high-titre inhibitor

Montoro, Julia; Altisent, Carme; Pico, M.; Cabañas, María José Ciudad; Vila, Marta; Puig, L.

doi:10.1111/j.1365-2516.1998.00186.x

Cited by 15 publications

(21 citation statements)

References 7 publications

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“…The coagulation factor VIIa is a significant component of the coagulation cascades and definitely participates in the predicted KEGG pathway [75]. This and similar drugs have a half-life of exactly 3.5 hours (between 1 h and 4 h), thereby confirming our prediction of the involvement of this KEGG pathway [76, 77]. …”

Section: Resultssupporting

confidence: 72%

The Use of Gene Ontology Term and KEGG Pathway Enrichment for Analysis of Drug Half-Life

et al. 2016

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A drug’s biological half-life is defined as the time required for the human body to metabolize or eliminate 50% of the initial drug dosage. Correctly measuring the half-life of a given drug is helpful for the safe and accurate usage of the drug. In this study, we investigated which gene ontology (GO) terms and biological pathways were highly related to the determination of drug half-life. The investigated drugs, with known half-lives, were analyzed based on their enrichment scores for associated GO terms and KEGG pathways. These scores indicate which GO terms or KEGG pathways the drug targets. The feature selection method, minimum redundancy maximum relevance, was used to analyze these GO terms and KEGG pathways and to identify important GO terms and pathways, such as sodium-independent organic anion transmembrane transporter activity (GO:0015347), monoamine transmembrane transporter activity (GO:0008504), negative regulation of synaptic transmission (GO:0050805), neuroactive ligand-receptor interaction (hsa04080), serotonergic synapse (hsa04726), and linoleic acid metabolism (hsa00591), among others. This analysis confirmed our results and may show evidence for a new method in studying drug half-lives and building effective computational methods for the prediction of drug half-lives.

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Section: Resultssupporting

confidence: 72%

The Use of Gene Ontology Term and KEGG Pathway Enrichment for Analysis of Drug Half-Life

et al. 2016

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“…It has been suggested that continuous infusion rVIIa may be equally effective, with a 77% reduction in factor requirement. If this proves to be the case and is a licensed procedure, it will be a significant advance ( Montoro et al , 1998 )…”

Section: Discussionmentioning

confidence: 99%

Central venous access devices in children with congenital coagulation disorders: complications and long‐term outcome

et al. 2000

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Summary. Reliable venous access is essential to facilitate the administration of prophylactic factor concentrate or blood products in children with congenital coagulation disorders and immune tolerance therapy (ITT) regimens in those who develop high responding inhibitors. Poor venous access is even more problematic in very young children, the vast majority of whom will require the insertion of central venous access devices (CVADs). Previous studies have suggested that infection rates are low and that there are few long-term complications associated with CVAD usage. We have reviewed 86 CVADs that have been inserted, since 1988, in 58 children with congenital bleeding disorders, aged 6 d to 16´5 years, attending Great Ormond Street Hospital, London, and the National Children's Hospital, Dublin. The devices have remained in situ for 2 weeks to 92 months (median 22´5 months). Early (0±2 weeks) complications of CVAD insertion included nine bleeding episodes, one extravasation of factor concentrate, three allergic reactions to factor concentrate and five catheter infections. Overall, CVAD infection was the commonest problem encountered, with 52 devices (60%) becoming infected. Twenty-seven CVADs (31%) required removal. Infection rates in children without inhibitors (29/68) were 1/20 patient±months or 1´6 infections/1000 patient±days, but infection rates for those with inhibitors were 1/8´5 patient±months or 4´3/1000 patient±days. Staphylococcus epidermidis was the predominant organism (25/52) isolated. Blockage of CVAD (four) and catheter disconnection (four) were the most frequently occurring non-infectious long-term complications. Skin erosion of the port was also seen in three children, in one child at 20 months, in one at 29 months and in one at 34 months after insertion. This study demonstrates a high CVAD infection rate and highlights the long-term complications of CVAD usage.

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“…Only English language literature was considered. Fifty articles were subsequently identified [10–57]. Underlying coagulopathy and/or the results of rFVIIa treatment in congenital haemophilia patients with inhibitors could be ascertained in only 46 of the 50 articles identified.…”

Section: Methodsmentioning

confidence: 99%

Surgical Experience with rFVIIa (NovoSeven) in congenital haemophilia A and B patients with inhibitors to factors VIII or IX

2011

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Patients with congenital haemophilia with inhibitors are at risk of peri-operative bleeding complications, since replacement of the missing coagulation factor is ineffective, presenting a therapeutic challenge in elective or emergency surgery. Therefore, the management of peri-operative bleeding requires the use of bypassing agents, such as recombinant activated FVII (rFVIIa, NovoSeven(®) ). This article presents an updated evaluation of the safety and effectiveness of rFVIIa in the treatment of peri-operative bleeding in this patient population. Surgical and other medical procedures managed with rFVIIa from two randomized clinical trials, the Hemophilia Research Society/Hemophilia and Thrombosis Research Society (HRS/HTRS) registry databases and the medical literature were analysed. There were 395 rFVIIa-treated procedures (261 surgical, 89 dental and 45 other medical procedures) reported for 263 congenital haemophilia patients with inhibitors. In trials, initial rFVIIa dosing was 35-90 mcg kg(-1) bolus injection or 50 mcg kg(-1) h(-1) continuous infusion. Dosing in the registries and literature was more variable. Recombinant FVIIa effectiveness was comparable across data sources, with an overall rate of 84% (333/395). The incidence of thrombotic events was very low (0.4% of patients and 0.025% of procedures). Prior to the US approval of rFVIIa in 1999, surgical procedures in congenital haemophilia patients with inhibitors were often considered too risky. Recombinant FVIIa has consistently demonstrated effectiveness in treatment of bleeding in these patients during such procedures. Thrombotic events were rare. This analysis confirms the value of corroborating clinical trial results with post-marketing surveillance registries to assess small patient populations with clinically challenging management decisions.

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Recombinant factor VIIa in continuous infusion during central line insertion in a child with factor VIII high-titre inhibitor

Cited by 15 publications

References 7 publications

The Use of Gene Ontology Term and KEGG Pathway Enrichment for Analysis of Drug Half-Life

The Use of Gene Ontology Term and KEGG Pathway Enrichment for Analysis of Drug Half-Life

Central venous access devices in children with congenital coagulation disorders: complications and long‐term outcome

Surgical Experience with rFVIIa (NovoSeven) in congenital haemophilia A and B patients with inhibitors to factors VIII or IX

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