Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis
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Blood Coagul. Fibrinolysis · Apr 2000
Multicenter Study Clinical TrialPotential role of NovoSeven in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage.
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. ⋯ 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.
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Blood Coagul. Fibrinolysis · Apr 2000
Case ReportsEffect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery.
Recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) is being increasingly used to secure haemostasis in difficult clinical situations. The role of rFVIIa in the treatment of patients undergoing open-heart surgery for valvular heart disease was evaluated in an open pilot study. Study objectives included evaluation of blood loss, haemostatic effect and safety and laboratory parameters following rFVIIa administration. ⋯ No significant adverse events were reported. Laboratory parameters indicated a mean 18.5-fold (range 3.7-42) increase in FVII levels at 30 min postinjection and a mean reduction of 12 s (range 3-39 s) in prothrombin time. In conclusion, rFVIIa represents an effective and well-tolerated treatment for serious bleeding episodes both during cardiac surgery and postoperatively.