Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia

Lin, Yulia; Stanworth, Simon; Birchall, Janet; Dorée, Carolyn; Hyde, Chris

doi:10.1002/14651858.cd005011.pub3

Cited by 27 publications

(18 citation statements)

References 78 publications

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“…4,5,62 The half-life of Factor VII is approximately 6 hours whereas that of Factor II is 60 – 72 hours. 53 Moreover, the half-life of rFVIIa may be even shorter than 6 hours owing to the increased volume of distribution when compared with the longer plasma-derived Factor VII.…”

Section: Approved and Off-label Uses For Pccsmentioning

confidence: 99%

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Prothrombin Complex Concentrates for Bleeding in the Perioperative Setting

Ghadimi

Levy²,

Welsby³

2016

Anesthesia &Amp; Analgesia

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Prothrombin complex concentrates (PCCs) contain vitamin K-dependent clotting factors (II, VII, IX and X) and are marketed as 3 or 4 factor-PCC formulations dependent on the concentrations of Factor VII. PCCs rapidly restore deficient coagulation factor concentrations to achieve hemostasis, but as with all procoagulants, the effect is balanced against thromboembolic risk. The latter is dependent on both the dose of PCCs and individual patient prothrombotic predisposition. PCCs are Food and Drug Administration approved for the reversal of vitamin K antagonists in the setting of coagulopathy or bleeding and therefore can be administered in these patients when urgent surgery is required. There is, however, a growing experience with the off-label use of PCCs to treat patients with surgical coagulopathic bleeding. Despite their increasing use, there are limited prospective data related to the safety, efficacy, and dosing of PCCs for this indication. PCC administration in the perioperative setting may be tailored to the individual patient based on laboratory and clinical variables, including point-of-care coagulation testing, in order to balance hemostatic benefits while minimizing prothrombotic risk. Importantly, in patients with perioperative bleeding, other considerations should include treating additional sources of coagulopathy such as hypofibrinogenemia, thrombocytopenia and platelet disorders, or surgical sources of bleeding. Thromboembolic risk from excessive PCC dosing may be present well into the postoperative period after hemostasis is achieved owing to the relatively long half-life of prothrombin (Factor II, 60 – 72 hours). The integration of PCCs into comprehensive perioperative coagulation treatment algorithms for refractory bleeding is increasingly reported, but further studies are needed to better evaluate the safe and effective administration of these factor concentrates.

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Section: Approved and Off-label Uses For Pccsmentioning

confidence: 99%

“…The increased use of rFVIIa for this approved indication then spurred its off-label administration for the management of warfarin-related coagulopathy and refractory hemorrhage. 4,5 Revisiting the mechanisms of action of these agents will provide an understanding of their clinical applications and limitations.…”

Section: Introductionmentioning

confidence: 99%

Prothrombin Complex Concentrates for Bleeding in the Perioperative Setting

Ghadimi

Levy²,

Welsby³

2016

Anesthesia &Amp; Analgesia

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“…A recent Cochrane's systematic review has probably put an end to the hope of having the ''magic bullet'' for the management of any bleeding, asserting that: ''unrestricted, unevaluated administration of rFVIIa outside licensed uses does not seem justified on the basis of the RCTs identified and analysed in this review'' [45].…”

Section: Recombinant Activated Factor VIImentioning

confidence: 99%

Posttraumatic massive bleeding: a challenging multidisciplinary task

et al. 2010

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Massive bleeding is a key issue in the treatment of trauma and surgery. It does in fact account for more than 50% of all trauma-related deaths within the first 48 h following hospital admission, and it can significantly raise the mortality rate of any kind of surgery. Despite this great clinical relevance, evidence on the management of massive bleeding is surprisingly scarce, and its treatment is often based on empirical grounds. Successful treatment of massive haemorrhage depends on better understanding of the associated physiological changes as well as on good team work between the different specialists involved in the management of such a complex condition. The aim of this article is to provide an overview of the pathophysiology as well as of current treatment options of such a condition, including the new concept of "damage control resuscitation", which integrates permissive hypotension, haemostatic resuscitation and damage control surgery.

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“…7 Lin et al conducted a meta-analysis of 26 randomized controlled trials that analyzed the use of rFVIIa in patients without hemophilia. 8 A total of 1137 patients were given rFVIIa as an off-label prophylactic dose, and 2538 patients were given rFVIIA as an off-label therapeutic dose. Doses ranged from 5 lg/kg to many doses that totaled 360 lg/kg.…”

mentioning

confidence: 99%

“…The researchers were unable to determine what should be a recommended dose for off-label use of rFVIIa. 8 Despite this, the precise etiology of the current patient's considerable postoperative complications is elusive. The use of rFVIIa may be the primary cause; however, rFVIIa has been given many times in past cases, such as for patients with penetrating or blunt trauma, and these patients had had no postoperative complications.…”

mentioning

confidence: 99%

Late Postoperative Segmental Lung Infarction After Use of Recombinant Activated Factor VII to Achieve Hemostasis

Mangar¹,

Sprenker²,

Karlnoski³

et al. 2013

Journal of Gynecologic Surgery

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Background: Recombinant activated factor VII (rFVIIa) has been approved by the U.S. Food and Drug Administration (FDA) for treatment of bleeding in patients with hemophilia A and B and other inhibitors to coagulation factors VIII and IX. However, since rFVIIa's approval, off-label use has increased for clinical situations, leading to the development of numerous side-effects. Case: The clinical course is presented of a high-risk 33-year-old G 3 P 2-0-0-2 parturient with twin gestation, diagnosed with placenta increta via ultrasound during prenatal evaluations. The patient had a cesarean section and a planned hysterectomy after delivery. Significant bleeding was present perioperatively and postoperatively, despite preoperative placement of intraoperative internal tourniquets via bilateral hypogastric balloons. Multiple units of packed red blood cells, fresh frozen plasma, cryoprecipitate, albumin, platelets, and rFVIIa were administered to facilitate hemostasis. Following two doses of rFVIIa, a pulmonary infarction developed, requiring a late pulmonary lobectomy. Results: The patient had a full recovery. Conclusions: rFVIIa should be used as approved by the FDA. Off-label use of rFVIIa should only occur in extenuating emergent hemorrhage situations in which the benefits outweigh the risks of serious postoperative complications. ( J GYNECOL SURG 29:203)

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Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia

Abstract: The version presented here may differ from the published version. If citing, you are advised to consult the published version for pagination, volume/issue and date of publication Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia (Review)

Cited by 27 publications

References 78 publications

Prothrombin Complex Concentrates for Bleeding in the Perioperative Setting

Prothrombin Complex Concentrates for Bleeding in the Perioperative Setting

Posttraumatic massive bleeding: a challenging multidisciplinary task

Late Postoperative Segmental Lung Infarction After Use of Recombinant Activated Factor VII to Achieve Hemostasis

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