In:
Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. suppl_1 ( 2014-02)
Abstract:
Introduction: Retrospective series report varying rates of bleeding and infection with external ventricular drainage (EVD). There have been no prospective studies of these risks with systematic surveillance, threshold definitions or independent adjudication. Hypothesis: Risks of bleeding and infection in the ongoing CLEAR Phase III trial are not higher than those previously reported in EVD case series or earlier dose finding trials. Methods: Cases were prospectively enrolled after placement of EVD for obstructive IVH and randomized to receive thrice daily injections of 1mg/1ml of recombinant tissue plasminogen activator or placebo until clearance of the IVH or maximum 12 doses. All cases received daily CT scans and sampling of cerebrospinal fluid (CSF) for the first week. We counted any detected new hemorrhage or expansion of prior bleed on CT scan by 〉 5ml in volume or 〉 5mm in diameter, after placement of the EVD until 30 days after its removal. Symptomatic bleeds and infections were adjudicated by an independent committee, based on previously articulated criteria. Meta-analysis of published series of EVD placement was compiled using STATA software. Results: Growing or unstable hemorrhage was reported as a cause of exclusion from the trial in 42 of 3,794 cases (1.1%) screened for CLEAR III. The first 175 cases enrolled in CLEAR III have completed adjudication of adverse events. Twenty-five subjects (14.3%) experienced one or more new bleeds or expansions, including 2 symptomatic hemorrhages (1.1%). Four cases (2.3%) had culture proven bacterial meningitis or ventriculitis, although many manifested varying sterile CSF pleocytosis in reaction to IVH. These rates were at the lower respective ranges of confidence intervals presently defined in meta-analysis of published series of EVD. Conclusion: The rates of new bleeds and bacterial meningitis/ventriculitis are very low with EVD for IVH, despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases and generalization to 〉 60 trial sites. Any independent risk related to thrombolysis awaits unblinding of results at trial completion.
Type of Medium:
Online Resource
ISSN:
0039-2499
,
1524-4628
DOI:
10.1161/str.45.suppl_1.wp252
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2014
detail.hit.zdb_id:
80381-9
detail.hit.zdb_id:
1467823-8
