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.