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Neurochirurgie
Volume 65, n° 1
pages 14-19 (février 2019)
Doi : 10.1016/j.neuchi.2018.11.004
Received : 18 September 2018 ;  accepted : 14 November 2018
Articles originaux

FIVHeMA: Intraventricular fibrinolysis versus external ventricular drainage alone in aneurysmal subarachnoid hemorrhage: A randomized controlled trial
 

T. Gaberel a, b, c, , C. Gakuba a, b, d, F. Fournel e, E. Le Blanc e, C. Gaillard e, L. Peyro-Saint-Paul e, F. Chaillot e, P. Tanguy a, c, J.-J. Parienti e, E. Emery a, b, c
a Department of neurosurgery, CHU de Caen, 14000 Caen, France 
b Inserm U1237 ‘physiopathology & imaging of neurological disorders’, university of Caen Normandy, 14000 Caen, 14000, France 
c Université Caen Normandie, Medical School, 14000 Caen, France 
d Department of intensive care medicine, CHU de Caen, 14000 Caen, France 
e Department of clinical research, CHU de Caen, 14000 Caen, France 

Corresponding author at: service de neurochirurgie, CHU de Caen, avenue de la Côte-de-Nacre, 14000 Caen, France.France
Abstract
Introduction

Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, which often causes acute hydrocephalus requiring the insertion of an external ventricular drain (EVD). A major complication of aneurysmal SAH is delayed cerebral ischemia (DCI). As DCI is linked to the presence of blood within the subarachnoid space, it has been hypothesized that removing this blood may decrease the risk of DCI. This could be achieved by injecting a fibrinolytic agent through the EVD, a strategy called intraventricular fibrinolysis (IVF). Here, we propose to conduct a phase III trial to directly evaluate the impact of IVF after aneurysmal SAH.

Materials and methods

We will perform an open-label randomized controlled trial comparing the standard of care, i.e. EVD alone, to the experimental treatment, i.e. IVF. We plan to include 440 patients to be able to show a 10% increase in the rate of good functional outcomes in the EVD+IVF group compared to the EVD alone group (α =0.05 and β =0.8). To obtain such sample, a multicenter trial is required, and to date 17 research sites in France have agreed to participate.

Perspective

FIVHeMA would be the first phase III trial evaluating the relevance of IVF in aneurysmal SAH. If IVF is shown to be beneficial, then a new therapeutic tool will be available to improve the outcomes of aneurysmal SAH patients.

The full text of this article is available in PDF format.

Keywords : Subarachnoid hemorrhage, Intracranial aneurysm, External ventricular drainage, Intraventricular fibrinolysis, Tissue plasminogen activator, Delayed cerebral ischemia




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