Recombinant activated factor VII in children with acute bleeding resulting from liver failure and disseminated intravascular coagulation

Chuansumrit, Ampaiwan; Chantarojanasiri, Tanyaporn; Isarangkura, P; Teeraratkul, Sumate; Hongeng, Suradej; Hathirat, P

doi:10.1097/00001721-200004001-00019

Cited by 67 publications

(37 citation statements)

References 3 publications

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“…In patients with and without liver diseases, administration of rFVIIa shortened the abnormal PT value [119][120][121][122][123][124]. However, in randomized clinical trials rFVIIa administration to patients with cirrhosis proved ineffective in controlling bleeding from varices or bleeding during surgery [24,120,[125][126][127].…”

Section: Recombinant Activated Factor VIImentioning

confidence: 99%

Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference

Andriulli

Tripodi

Angeli

et al. 2016

Digestive and Liver Disease

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a b s t r a c tPatients with cirrhosis present with hemostatic alterations secondary to reduced availability of procoagulant and anti-coagulant factors. The net effect of these changes is a rebalanced hemostatic system. The Italian Association of the Study of the Liver (AISF) and the Italian Society of Internal Medicine (SIMI) promoted a consensus conference on the hemostatic balance in patients with cirrhosis. The consensus process started with the review of the literature by a scientific board of experts and ended with a formal consensus meeting in Rome in December 2014. The statements were graded according to quality of evidence and strength of recommendations, and approved by an independent jury. The statements presented here highlight strengths and weaknesses of current laboratory tests to assess bleeding and thrombotic risk in cirrhotic patients, the pathophysiology of hemostatic perturbations in this condition, and outline the optimal management of bleeding and thrombosis in patients with liver cirrhosis.

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Section: Recombinant Activated Factor VIImentioning

confidence: 99%

Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference

Andriulli

Tripodi

Angeli

et al. 2016

Digestive and Liver Disease

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“…Additionally, rFVIIa has been shown to inhibit fibrinolysis by activation of the thrombin activatable fibrinolysis inhibitor (TAFI) (Lisman et al, 2002). The use of rFVIIa to control bleeding has been reported in various clinical settings, including the treatment of both coagulopathic and hemostatically normal patients peri-surgically (Friederich et al, 2003;Aldouri, 2002), post-trauma (Martinowitz et al, 2001(Martinowitz et al, , 2002Kenet et al, 1999;Kamphuisen et al, 2002;O'Neill et al, 2002;Khan et al, 2005;Filsoufi et al, 2006), in liver failure (Chuansumrit et al, 2000) and in other bleeding conditions refractory to conventional therapy (Mayo et al, 2004). Of particular interest are the encouraging results to date for use of rFVIIa following spontaneous intracerebral hemorrhage (ICH) (Mayer et al, 2005a,b;Steiner et al, 2006) where rFVIIa was reported to decrease hematoma growth, reduce mortality, and improve functional outcome.…”

Section: Introductionmentioning

confidence: 99%

Hemostatic and neuroprotective effects of human recombinant activated factor VII therapy after traumatic brain injury in pigs

Zhang¹,

Groff²,

Chen³

et al. 2008

Experimental Neurology

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Human recombinant activated factor-VII (rFVIIa) has been used successfully in the treatment of spontaneous intracerebral hemorrhage. In addition, there is increasing interest in its use to treat uncontrolled bleeding of other origins, including trauma. The aim of this study was to evaluate the safety and potential effectiveness of rFVIIa to mitigate bleeding using a clinically relevant model of traumatic brain injury (TBI) in the pig. A double injury model was chosen consisting of (1) an expanding cerebral contusion induced by the application of negative pressure to the exposed cortical surface and (2) a rapid rotational acceleration of the head to induce diffuse axonal injury (DAI). Injuries were performed on 10 anesthetized pigs. Five minutes after injury, 720 μg/kg rFVIIa (n = 5) or vehicle control (n = 5) was administered intravenously. Magnetic resonance imaging (MRI) studies were performed within 30 min and at 3 days post-TBI to determine the temporal expansion of the cerebral contusion. Euthanasia and histopathologic analysis were performed at day 3. This included observations for hippocampal neuronal degeneration, axonal pathology and microclot formation. The expansion of contusion volume over the 3 days postinjury period was reduced significantly in animals treated with rFVIIa compared to vehicle controls. Surprisingly, immunohistochemical analysis demonstrated that the number of dead/dying hippocampal neurons and axonal pathology was reduced substantially by rFVIIa treatment compared to vehicle. In addition, there was no difference in the extent of microthrombi between groups. rFVIIa treatment after TBI in the pig reduced expansion of hemorrhagic cerebral contusion volume without exacerbating the severity of microclot formation. Finally, rFVIIa treatment provided a surprising neuroprotective effect by reducing hippocampal neuron degeneration as well as the extent of DAI.

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“…Interestingly, reports in bleeding patients with DIC and/or microangiopathic hemolytic anemia showed successful administration of recombinant factor VIIa without adverse events. 37,38 In addition, an uncontrolled pilot study in 6 patients undergoing liver transplantation showed a remarkable reduction in transfusion requirements (as compared with historical controls) and no adverse events. 39 Transfusion Alternatives in Transfusion Medicine VOLUME 5 NUMBER 5 SUPPLEMENT DECEMBER 2003 Lastly, the potential of recombinant factor VIIa to reduce perioperative blood loss and decrease transfusion requirements in patients with an a priori normal coagulation system was investigated in a randomized placebo-controlled trial in men undergoing transabdominal prostatectomy.…”

Section: Thrombotic Complications Of Recombinant Factor Viia In Surgerymentioning

confidence: 98%

Safety of Recombinant Factor VIIa

Levi

2003

Transfus Alt Transfus Med

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Recombinant activated factor VII is an activator of blood coagulation that is highly effective as a hemostatic agent in patients with complicated hemophilia and other clotting disorders who experience major bleeding or need to undergo surgery.In recent years the potential of this agent to reduce perioperative bleeding and transfusion requirements in non-hemophilia patients with excessive bleeding, for example after trauma or major surgical interventions, has been studied. Also, the use of recombinant factor VIIa to prevent bleeding and blood transfusion in patients who need to undergo invasive procedures that are associated with major blood loss has been investigated. Most of these observations and trials show efficacy of recombinant factor VIIa in reducing blood loss and the requirement for blood transfusion. Every prohemostatic intervention carries the risk of adverse events, in particular thrombosis. However, the initial reports show that adverse events due to recombinant factor VIIa are not frequent, although definitive conclusions regarding the safety of this approach should await larger trials.

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Recombinant activated factor VII in children with acute bleeding resulting from liver failure and disseminated intravascular coagulation

Cited by 67 publications

References 3 publications

Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference

Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference

Hemostatic and neuroprotective effects of human recombinant activated factor VII therapy after traumatic brain injury in pigs

Safety of Recombinant Factor VIIa

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