The use of recombinant activated Factor VII in the control of haemorrhage following blunt pelvic trauma

Udy, Andrew; Vaghela, Maheshkumar Manilal; Lawton, G.; Sigston, P.

doi:10.1111/j.1365-2044.2005.04154.x

Cited by 16 publications

(5 citation statements)

References 21 publications

(18 reference statements)

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“…As of today, there are not many studies available that help us understand whether there is a place for rFVIIa in these kinds of surgery. An optimistic case description reported on dramatic reduction of bleeding in two traumatized pelvic fracture victims after a single dose of rFVIIa at around 70 µg/kg 29 . A randomized controlled study on reconstructive pelvic fracture surgery approached this issue in a controlled fashion 30 .…”

Section: Patients Without Hemophiliamentioning

confidence: 99%

Role of recombinant activated factor VII as hemostatic support in orthopedic surgery

Ingerslev

Sørensen

2006

Transfus Alt Transfus Med

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35 Journal Compilation © 2006 LMS Group • Transfusion Alternatives in Transfusion Medicine Transfusion Alternatives in Transfusion Medicine TATM S U M M A R YThe purpose of this overview is to collect available literature on the use of recombinant activated factor VII (rFVIIa) in conjunction with orthopedic surgery, and to describe and discuss the efficacy of rFVIIa in such procedures. The review deals with surgical procedures carried out in patients with hemophilia complicated by the presence of inhibitors (alloantibodies) against the missing coagulation factor as well as procedures carried out in persons with no pre-existing coagulation disorder. One randomized controlled clinical trial has been performed in hemophilia patients with inhibitors, but no other controlled studies were identified. Data collected show that rFVIIa is highly efficacious in the prevention and management of surgical bleeds in most hemophilia patients with inhibitors when frequent bolus injections of 100 µ g/kg body weight of rFVIIa was adopted, while data from cases managed with a continuous infusion technology were less clear. In particular, the optimal infusion rate of rFVIIa needs clarification. In orthopedic patients with no known pre-existing coagulation disorder, data gathered during the review show that rFVIIa reduces the blood loss in severe blunt trauma, while the effect on bleeding by rFVIIa in elective orthopedic procedures needs further clarification.

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Section: Patients Without Hemophiliamentioning

confidence: 99%

Role of recombinant activated factor VII as hemostatic support in orthopedic surgery

Ingerslev

Sørensen

2006

Transfus Alt Transfus Med

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“…1 In addition, both research investigators and clinicians treating patients with severe hemorrhaging have employed rFVIIa as a potential "universal hemostatic agent" in diverse scenarios for which there is no licensed indication. 2 These have included treating patients with presumed deficiencies or antibody-neutralization of other clotting factors besides FVII, FVIII or FIX (e.g., patients with congenital or acquired FXI deficiency 3 ); patients with qualitative or quantitative platelet defects (e.g., alloimmune thrombocytopenia after chronic platelet transfusion or Glanzmann's thrombasthenia 4 ) or vascular injury states (e.g., spontaneous ICH or blunt trauma [5][6][7][8][9][10][11] ) in which either no identifiable coagulopathy is present or in which all efforts to correct associated cellular and/or biochemical defects have failed to stop hemorrhaging. These "off-label" uses of rFVIIa will be the focus of this discussion.…”

Section: W Keith Hootsmentioning

confidence: 99%

Challenges in the Therapeutic Use of a “So-Called” Universal Hemostatic Agent: Recombinant Factor VIIa

Hoots¹

2006

Hematology

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Recombinant factor VIIa (rFVIIa) was developed in the early 1990s to provide “bypassing” hemostatic therapy for hemophilia A and B patients with inhibitors. More recently, it has been licensed for use in patients with inherited deficiency of factor VII. Since it was licensed for use in hemophilia with inhibitors in the US, Europe, and other countries for these specific indications, it has been used selectively but in a wide array of clinical settings for uncontrolled hemorrhage in individuals without an inherited bleeding disorder. Many of these uses have been described in the medical literature as case reports or small, uncontrolled series. Several randomized clinical trials (RCT) for these “off-label” medical uses have been published in recent months and will serve as the focus of this review. In particular, a review of an RCT for spontaneous intracranial hemorrhage that has demonstrated clinical efficacy in reducing both mortality and volume of central nervous system hemorrhage will be offered. A brief discussion of hypothesized physiologic mechanisms of supraphysiologic doses of rFVIIa will introduce the clinical discussion of these broad off-label uses. Since rFVIIa is a very expensive therapy, possible strategies for optimizing its use in the these settings will be presented.

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“…We were interested to read the case reports by Udy et al . [1]. The evidence for the use of activated Factor VII in haemorrhage is, at present, mostly limited to case series or reports and retrospective analysis; hence its use in trauma and haemorrhage is on a ‘compassionate’ basis.…”

mentioning

confidence: 99%

A response to ‘The use of recombinant activated Factor VII in the control of haemorrhage following blunt pelvic trauma

Geoghegan¹,

Tasker²

2005

Anaesthesia

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The use of recombinant activated Factor VII in the control of haemorrhage following blunt pelvic trauma

Cited by 16 publications

References 21 publications

Role of recombinant activated factor VII as hemostatic support in orthopedic surgery

Role of recombinant activated factor VII as hemostatic support in orthopedic surgery

Challenges in the Therapeutic Use of a “So-Called” Universal Hemostatic Agent: Recombinant Factor VIIa

A response to ‘The use of recombinant activated Factor VII in the control of haemorrhage following blunt pelvic trauma

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