Bleeding and Infection With External Ventricular Drainage

Abstract

Background Retrospective series report varied 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. Objective We analyzed the rate of complications in the ongoing CLEAR III trial, providing a comparison with a systematic review of complications of EVD in the literature. Methods Cases were prospectively enrolled in the CLEAR III trial after placement of EVD for obstructive intraventricular hemorrhage (IVH) and randomized to receive recombinant tissue plasminogen activator (rt-PA) or placebo. We counted any detected new hemorrhage (catheter tract hemorrhage or any other distant hemorrhage) on CT scan within 30 days from the randomization. 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 74 of 5707 cases (1.3%) screened for CLEAR III. The first 250 cases enrolled have completed adjudication of adverse events. Forty-two subjects (16.8%) experienced one or more new bleeds or expansions, and 6 of 250 subjects (2.4%) suffered symptomatic hemorrhages. Eleven cases (4.4%) had culture-proven bacterial meningitis or ventriculitis. Conclusion Risks of bleeding and infection in the ongoing CLEAR III trial are comparable to those previously reported in EVD case series. In the current study, rates of new bleeds and bacterial meningitis/ventriculitis are very low, despite multiple daily injections, blood in the ventricles, the use of thrombolysis in half the cases, and generalization to > 60 trial sites.

The Incidence of Catheter Tract Hemorrhage and Catheter Placement Accuracy in the CLEAR III Trial

“…The pooled incidence of symptomatic catheter-related hemorrhage of 0.7% (range 0–14.6%) reported by Dey [6] compares with our finding of 0.2% ( n = 1) in the prerandomization phase of CLEAR III. Definitions of symptomatic hemorrhage are limited, however, with retrospective reports lacking a standard definition of deterioration.…”

“…Dey et al [6] reported a pooled incidence of hemorrhagic complications after EVD placement of 8.4% (range from < 1 to 41%). This review included a heterogeneous population with SAH, TBI, IVH, and brain tumors as indications for EVD placement [8, 9, 13–17].…”

“…In contrast to infection, catheter tract hemorrhage (CTH) has received significantly less attention in the literature. Reported rates of new or expanded hemorrhage after ventriculostomy range from 0.7 to 41% [6–9]. Dey et al [6] in a systematic review of bleeding and hemorrhage risks with EVD use attributed the wide variation to lack of standard definitions for ascertaining the presence of CTH.…”

“…Reported rates of new or expanded hemorrhage after ventriculostomy range from 0.7 to 41% [6–9]. Dey et al [6] in a systematic review of bleeding and hemorrhage risks with EVD use attributed the wide variation to lack of standard definitions for ascertaining the presence of CTH. Age > 75 years, international normalized ratio (INR) > 1.4, and use of antithrombotic agents have been identified as risk factors for CTH [10–12].…”

Randomized, Open-Label, Phase 1/2a Study to Determine the Maximum Tolerated Dose of Intraventricular Sustained Release Nimodipine for Subarachnoid Hemorrhage (NEWTON [Nimodipine Microparticles to Enhance Recovery While Reducing Toxicity After Subarachnoid Hemorrhage])

“…This infection rate is comparable to analysis of 33 studies with 9667 cases from the literature that found a pooled infection incidence of 8%. 31 This study allowed for institutional practice to be followed for EVD insertion. There was no study-mandated protocol for EVD insertion.…”