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Open Access Study protocol

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

Jürgen Bardutzky1, Jens Witsch23*, Eric Jüttler23, Stefan Schwab4, Peter Vajkoczy5 and Stefan Wolf5

Author Affiliations

1 Department of Neurology, Albert-Ludwigs-University Freiburg, Breisacherstr. 64, 79106 Freiburg, Germany

2 Charité Center for Stroke Research Berlin (CSB), Campus Virchow Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany

3 Department of Neurology, Charité Campus Virchow Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany

4 Department of Neurology, Friedrich-Alexander-Universität Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany

5 Department of Neurosurgery, Charité Campus Virchow Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany

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Trials 2011, 12:203  doi:10.1186/1745-6215-12-203

Published: 14 September 2011

Abstract

Background

Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.

In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet.

Methods/Design

This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge.

Discussion

Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.

Trial registration

www.clinicaltrials.gov Identifier: NCT01258257