Reconstituted recombinant factor VIII can be safely infused continuously for at least three days

Me, Didier; Fischer, Shelly; Dg, Maki

doi:10.1097/00001721-199804000-00002

Cited by 8 publications

(9 citation statements)

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“…As CI was first suggested as an improvement over BI for treating haemophilia patients [3] it has proven to be safe and effective and consequently advocated by a number of reviews [13,20,23,24]. Early studies first demonstrated its effectiveness [12,13,[25][26][27] while later concerns regarding stability and safety were dispelled by the results of research carried out in the 1990s [4][5][6][7][8][9][10][11]. Today CI has become a widely used approach in the management of haemophilia.…”

Section: Discussionmentioning

confidence: 99%

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Retrospective audit of a continuous infusion protocol for haemophilia A at a single haemophilia treatment centre

2005

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Continuous infusion (CI) of factor concentrates has been suggested to decrease the risk of bleeding and reduce cost in the treatment of bleeding disorders. Concerns have also been raised regarding stability and sterility of products administered by CI, the risk of local thrombophlebitis and an association with the development of an inhibitor in mild haemophilia. A retrospective chart review was conducted to investigate a CI protocol regarding product use, maintenance of FVIII levels and the frequency of complications including inhibitor development. Twelve patients with haemophilia A received recombinant factor VIII by CI a total of 18 times between April 1998 and September 2003. Ages ranged from 4 months to 75 years and indications for treatment included severe bleeds and surgical prophylaxis. The protocol which was audited required a bolus of 50 U kg(-1) of FVIII followed by CI at an initial rate of 4 U kg(-1) hr(-1). All infusions were administered by i.v. infusion after diluting the reconstituted concentrate in saline. There were no documented cases of significant bleeding, adverse reactions, thrombophlebitis or infection. Two mild haemophilia A patients developed a low titre inhibitor after receiving CI. It is not clear in either case that CI was the main contributing factor. Our CI protocol will now be modified to use less product, aiming for more cost-effectiveness.

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Section: Discussionmentioning

confidence: 99%

“…Most of the recent literature reports a protocol using mini-pumps in the delivery of CI [11,20,23,[28][29][30][31]. As well as being more convenient, mini-pumps have eliminated the need to dilute product in large volumes of saline, which has been found to result in a loss of activity of the replacement product [8,9].…”

Section: Discussionmentioning

confidence: 99%

Retrospective audit of a continuous infusion protocol for haemophilia A at a single haemophilia treatment centre

2005

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“…Indeed, no patient in the series of Schulman et al [18] or our own cohort developed sepsis related to the infusion. Recently, Didier et al [19] have shown that recombinant FVIII can be reconstituted and infused continuously for up to 3 days without any risk of sepsis, because it is a poor microbial growth medium. However, hospital pharmacies must use sterile techniques to prepare FVIII for infusion.…”

Section: Discussionmentioning

confidence: 99%

Continuous factor VIII infusion therapy in patients with haemophilia A undergoing surgical procedures with plasma‐derived or recombinant factor VIII concentrates

Dingli¹,

Gastineau

Gilchrist

et al. 2002

Haemophilia

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We describe the experience of a single medical centre with continuous factor VIII (FVIII) infusion therapy in a cohort of patients undergoing elective surgery. Twenty-eight patients had a total of 45 procedures. Intraoperative haemostasis was considered excellent in all 45 cases. FVIII levels were maintained between 46% and 191% of normal (median, 103%) for 2-7 days. Bleeding occurred after five procedures (11%) at times when factor VIII levels were within haemostatic range. No patient required reoperation to control bleeding. There were no cases of sepsis related to continuous infusion of factor VIII. We conclude that continuous infusion: (1) is a safe and effective means of replacement therapy in patients with haemophilia undergoing surgery; (2) provides easier monitoring and more constant coagulation factor levels; and (3) has the potential to decrease the cost of replacement therapy by reducing overall usage of product.

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Section: Feasibility Of Continuous Infusion: Problems and Solutionsmentioning

confidence: 99%

“…Studies using inoculation of bacteria into reconstituted concentrates showed that the products tested did not support bacterial overgrowth [8]. In addition, recent studies with a wide variety of bacterial species have proved that both plasma-derived and recombinant FVIII and factor IX (FIX) concentrates are poor growth media for bacteria [11,13,19]. However, Belgaumi et al [20] reported the growth of several bacteria strains after the inoculation of rFVIII (Bioclate, Centeon), suggesting its nutritive capability for sustaining bacterial growth, whereas in plasma-derived FVIII and FIX concentrates, no bacteria other than Pseudomonas aeruginosa reached a significant growth after 48 h incubation [11].…”

Section: Microbial Safety and Infectious Risksmentioning

confidence: 99%

Continuous infusion of coagulation factors

Bátorová

Martinowitz

2002

Haemophilia

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Reconstituted recombinant factor VIII can be safely infused continuously for at least three days

Cited by 8 publications

References 0 publications

Retrospective audit of a continuous infusion protocol for haemophilia A at a single haemophilia treatment centre

Retrospective audit of a continuous infusion protocol for haemophilia A at a single haemophilia treatment centre

Continuous factor VIII infusion therapy in patients with haemophilia A undergoing surgical procedures with plasma‐derived or recombinant factor VIII concentrates

Continuous infusion of coagulation factors

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