Potential role of NovoSeven® in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage
Authors: Pickard, J.D., Gelling, L. et al.
Journal: Blood Coagulation and Fibrinolysis
Volume: 11
Issue: 4 SUPPL. 1
ISSN: 0957-5235
DOI: 10.1097/00001721-200004001-00022
Abstract:Rebleeding following aneurysmal subarachnoid haemorrhage is a major factor contributing to unfavourable outcome. Antifibrinolytic agents reduce the rate of rebleeding but increase the risk of cerebral ischaemia and infarction and hence provide no overall benefit. To address the theoretical concern that recombinant activated factor VII (NovoSeven®, Novo Nordisk A/S, Bagsvaerd, Denmark) might increase the risk of cerebral ischaemia while stabilizing the clot at the site of aneurysmal rupture, an open-label, dose- escalation safety study has been developed in collaboration with the UK Spontaneous Intracranial Haemorrhage Group. The trial design includes the recruitment of 15 patients (aged 18 years or over) in good grade with subarachnoid haemorrhage verified by computerized tomography scan or lumbar puncture. Safety evaluation includes clinical observation, monitoring of laboratory variables, positron emission tomography (PET) scanning (rCBF, rOEF, rCMRO2) and transcranial Doppler ultrasound. To date, ten patients have been recruited [NovoSeven® 80 μg/kg single bolus (n = 2), NovoSeven® 80 μg/kg single bolus followed by continuous infusion at 3.5 μg/kg per h (n = 2) or 7 μg/kg per h (n = 1), or control (n = 5)]. Clinical observation, transcranial Doppler ultrasound and PET studies revealed no evidence of cerebral ischaemia in the first nine patients treated with NovoSeven®. The last patient developed middle cerebral artery branch thrombosis contralateral to the aneurysm. The study is currently suspended pending further investigation. (C) 2000 Lippincott Williams and Wilkins.
Source: Scopus
Potential role of NovoSeven in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage.
Authors: Pickard, J.D., Gelling, L. et al.
Journal: Blood Coagul Fibrinolysis
Volume: 11 Suppl 1
Pages: S117-S120
ISSN: 0957-5235
DOI: 10.1097/00001721-200004001-00022
Abstract:Rebleeding following aneurysmal subarachnoid haemorrhage is a major factor contributing to unfavourable outcome. Antifibrinolytic agents reduce the rate of rebleeding but increase the risk of cerebral ischaemia and infarction and hence provide no overall benefit. To address the theoretical concern that recombinant activated factor VII (NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) might increase the risk of cerebral ischaemia while stabilizing the clot at the site of aneurysmal rupture, an open-label, dose-escalation safety study has been developed in collaboration with the UK Spontaneous Intracranial Haemorrhage Group. The trial design includes the recruitment of 15 patients (aged 18 years or over) in good grade with subarachnoid haemorrhage verified by computerized tomography scan or lumbar puncture. Safety evaluation includes clinical observation, monitoring of laboratory variables, positron emission tomography (PET) scanning (rCBF, rOEF, rCMRO2) and transcranial Doppler ultrasound. To date, ten patients have been recruited [NovoSeven 80 microg/kg single bolus (n = 2), NovoSeven 80 microg/kg single bolus followed by continuous infusion at 3.5 microg/kg per h (n = 2) or 7 microg/kg per h (n = 1), or control (n = 5)]. Clinical observation, transcranial Doppler ultrasound and PET studies revealed no evidence of cerebral ischaemia in the first nine patients treated with NovoSeven. The last patient developed middle cerebral artery branch thrombosis contralateral to the aneurysm. The study is currently suspended pending further investigation.
Source: PubMed
Potential role of NovoSeven (R) in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage
Authors: Pickard, J.D., Gelling, L. et al.
Journal: BLOOD COAGULATION & FIBRINOLYSIS
Volume: 11
Pages: S117-S120
ISSN: 0957-5235
DOI: 10.1097/00001721-200004001-00022
Source: Web of Science (Lite)
Potential role of NovoSeven in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage.
Authors: Pickard, J.D., Gelling, L. et al.
Journal: Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis
Volume: 11 Suppl 1
Pages: S117-S120
eISSN: 1473-5733
ISSN: 0957-5235
DOI: 10.1097/00001721-200004001-00022
Abstract:Rebleeding following aneurysmal subarachnoid haemorrhage is a major factor contributing to unfavourable outcome. Antifibrinolytic agents reduce the rate of rebleeding but increase the risk of cerebral ischaemia and infarction and hence provide no overall benefit. To address the theoretical concern that recombinant activated factor VII (NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) might increase the risk of cerebral ischaemia while stabilizing the clot at the site of aneurysmal rupture, an open-label, dose-escalation safety study has been developed in collaboration with the UK Spontaneous Intracranial Haemorrhage Group. The trial design includes the recruitment of 15 patients (aged 18 years or over) in good grade with subarachnoid haemorrhage verified by computerized tomography scan or lumbar puncture. Safety evaluation includes clinical observation, monitoring of laboratory variables, positron emission tomography (PET) scanning (rCBF, rOEF, rCMRO2) and transcranial Doppler ultrasound. To date, ten patients have been recruited [NovoSeven 80 microg/kg single bolus (n = 2), NovoSeven 80 microg/kg single bolus followed by continuous infusion at 3.5 microg/kg per h (n = 2) or 7 microg/kg per h (n = 1), or control (n = 5)]. Clinical observation, transcranial Doppler ultrasound and PET studies revealed no evidence of cerebral ischaemia in the first nine patients treated with NovoSeven. The last patient developed middle cerebral artery branch thrombosis contralateral to the aneurysm. The study is currently suspended pending further investigation.
Source: Europe PubMed Central