Potential role of NovoSeven® in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage

Pickard, John D.; Kirkpatrick, Peter J.; Melsen, Tina; Andreasen, R. B.; Gelling, L.; Fryer, Tim D.; Matthews, Jeffrey B.; Minhas, Pawan Singh; Hutchinson, Peter J.; Menon, David; Downey, Susan; Kendall, I G; Clark, John C.; Carpenter, T. Adrian; Williams, Elisabeth; Persson, Lennart

doi:10.1097/00001721-200004001-00022

Cited by 61 publications

(29 citation statements)

References 5 publications

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“…Additionally, there have been reports of successful use of rFVIIa to control bleeding during neurosurgical procedures for resection of intracranial tumours 5 and to prevent rebleeding after aneurysmal subarachnoid haemorrhage without increasing the risk of cerebral infarction -a complication commonly associated with older antifibrinolytic agents. 6 Thus, there is emerging evidence that rFVIIa may be used successfully for the treatment of various types of intracranial bleeding, including reports of a small number of patients on warfarin anticoagulation. 7,8 Factor VII may be the coagulation factor most affected by oral vitamin K antagonists.…”

Section: Discussionmentioning

confidence: 99%

Recombinant activated factor VII for a warfarinised Jehovah’s Witness with an acute subdural haematoma

Goldberg

Drummond

2008

Journal of Clinical Neuroscience

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Section: Discussionmentioning

confidence: 99%

Recombinant activated factor VII for a warfarinised Jehovah’s Witness with an acute subdural haematoma

Goldberg

Drummond

2008

Journal of Clinical Neuroscience

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“…Un ensayo clínico sobre seguridad y dosificación del aFVIIr se suspendió cuando uno de los diez pacientes, tratado con 80 μg•Kg -1 en bolo y perfusión de 7 μg•Kg -1 •h -1 , presentó al 4º día de evolución un cuadro de hemiparesia en relación con embolismos múlti-ples en la arteria cerebral media contralateral al aneurisma, aunque no pudo demostrarse definitivamente la relación entre el fármaco y el evento trombótico 111 . El aFVIIr se ha empleado como tratamiento preventivo en una serie de 18 clipajes aneurismáticos 104 .…”

Section: B Hemorragia Subaracnoidea Espontánea Y Procedimientos Neurunclassified

Rol del factor VII recombinante activado en pacientes neuroquirúrgicos y neurocríticos

et al. 2011

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ResumenLa hemorragia del sistema nervioso central constituye una patología grave, ya que un volumen de sangrado relativamente pequeño en el cerebro puede presentar consecuencias devastadoras. La utilización de agentes hemostáticos pueden reducir las consecuencias de la hemorragia cerebral espontánea, traumática o secundaria a la anticoagulación. El Factor VII recombinante activado (rFVIIa) es un fármaco procoagulante que se ha empleado en diversas patologías hemorrágicas del sistema nervioso central, si bien esta indicación no se recoge en la ficha técnica del fármaco. En esta revisión se repasa el mecanismo de actuación del fármaco, su potencial en el tratamiento de la hemorragia del sistema nervioso central y las evidencias existentes al respecto.Se realizó una revisión de la bibliografía disponible sobre el uso de rFVIIa en el control de la hemorragia relacionada con el sistema nervioso central, la patología neurocrítica y procedimientos neuroquirúrgicos, mediante búsqueda en MEDLINE y en el registro de ensayos clínicos: http://clinicaltrials.gov (última revisión septiembre 2010), además de revisión manual de las publicaciones a partir de la bibliografía de los artí-culos recuperados.En la hemorragia cerebral espontánea, existen ensayos clínicos aleatorios, cuyos resultados desaconsejan la utilización sistemática del fármaco en esta indicación. En el resto de hemorragias relacionadas con el sistema nervioso central, los datos existentes se basan en estudios retrospectivos, opiniones de expertos o casos clíni-cos aislados.PALABRAS CLAVE. Desórdenes de la coagulación. Hemorragia intracraneal. Factor VII recombinante activado. Cuidados críticos.The role of recombinant activated factor VII in neurosurgical and neurocritical patients Summary Central nervous system haemorrhage is a severe pathology, as a small amount of bleeding inside the brain can result in devastating consequences. Haemostatic agents might decrease the consequences of intracranial bleeding, whichever spontaneous, traumatic, or anticoagulation treatment etiology. Proacogulant recombinant activated factor VII (rFVIIa) has been given after central nervous system bleeding, with an off-label indication. In this update, we go over the drug mechanism of action, its role in the treatment of central nervous system haemorrhage and the published evidences regarding this subject.We carried out a literature review concerning the treatment with rFVIIa in central nervous system haemorrhage, neurocritical pathologies and neurosurgical procedures, searching in MEDLINE and in clinical trials registry: http://clinicaltrials.gov (last review September 2010), as well as performing a manual analysis of collected articles, looking for aditional references.The results of randomized clinical trials do not support the systematic administration of rFVIIa for spontaneous intracranial cerebral haemorrhage. In other central nervous system related haemorrhages, the current available data consist on retrospective studies, expert opinion or isolated case reports.KEY WORDS. Bloo...

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“…The drug half-life is only 2.3 h, and onset of effect is observed within 20 min of administration [6,22]. Although the potential usefulness of rFVIIa has gained increasing recognition in the neurosurgical literature [8,11,33], enthusiasm for its use has been tempered by safety concerns including the potential for thromboembolic complications [34,40]. Any study evaluating the use of rFVIIa in SAH will have to address the possibility of an increased risk for cerebral vasospasm, hydrocephalus, or thromboembolic sequelae.…”

Section: Recombinant Activated Factor VII and Neurosurgerymentioning

confidence: 99%

“…In a more recent study evaluating the use of rFVIIa to prevent aneurysmal rebleeding, Pickard et al [34] enrolled 10 patients in an open label, dose escalation safety trial. Two patients received an 80 lg/kg single bolus, two received an 80 lg/kg bolus followed by continuous infusion at 3.5 lg/kg/h, and one patient received an infusion of 7 lg/kg.…”

Section: Recombinant Activated Factor VII and Neurosurgerymentioning

confidence: 99%

Perioperative Use of Recombinant Factor VII to Prevent Intraoperative Aneurysm Rupture in High Risk Patients: A Preliminary Safety Evaluation

et al. 2008

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We describe our experience with the use of a single dose of rFVIIa administered perioperatively in an attempt to decrease the rate of intraoperative aneurysm rupture in patients undergoing microsurgical aneurysm clipping. There were no significant immediate or long-term adverse effects attributable to the use of rFVIIa in this group, and we encountered no intraoperative ruptures in this relatively small series.

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Potential role of NovoSeven® in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage

Cited by 61 publications

References 5 publications

Recombinant activated factor VII for a warfarinised Jehovah’s Witness with an acute subdural haematoma

Recombinant activated factor VII for a warfarinised Jehovah’s Witness with an acute subdural haematoma

Rol del factor VII recombinante activado en pacientes neuroquirúrgicos y neurocríticos

Perioperative Use of Recombinant Factor VII to Prevent Intraoperative Aneurysm Rupture in High Risk Patients: A Preliminary Safety Evaluation

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