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• W2607887939 abstract "Patients suffering from intracerebral hemorrhage (ICH) with intraventricular hemorrhage (IVH) face dismal prognosis both in terms of survival and ultimate functional outcome. Roughly 40% of patients with ICH additionally experience IVH, which has been shown to be an independent predictor of poor prognosis.1 As such, efforts have been made to specifically address the presence of ventricular blood in these patients in an attempt to improve outcomes. In theory, by clearing intraventricular blood, clinicians can mitigate its associated complications, namely obstructive hydrocephalus and herniation. In practice, these efforts include placement of ventriculostomy catheters, use of intraventricular thrombolytics, and even endoscopic clot evacuation. While some studies suggest that use of such techniques can indeed improve clinical outcomes,2 to date, there are no well-defined prospective randomized control studies assessing functional outcomes in this subset of patients. Furthermore, in a time of increasing standardization of stroke patient management, there is very little uniformity in IVH intervention guidelines, with current recommendations being only class IIb and based on level B evidence.3 The CLEAR III trial has endeavored to provide more granular evidence in support of IVH-clearing interventions. A recent paper by Hanley et al published in The Lancet4 presents the results of this trial, a multicenter, multiregional, double-blinded, randomized placebo control study evaluating intraventricular alteplase's efficacy in improving functional outcomes in IVH patients. During the study, 500 patients who had suffered IVH were randomized to receiving intraventricular alteplase vs saline. Patients were eligible for enrollment if ICH/IVH was supratentorial and 30 mL or less in volume, had a previous modified Rankin Scale (mRS) score of 1 or less, no ongoing coagulopathy, and no suspicion for vascular malformations. All patients were required to have had an external ventricular drain (EVD) placed prior to enrollment and at least 6 h of hematoma stability following EVD placement. Once enrolled and randomized, patients received either 1 mg of alteplase or 0.9% saline intraventricularly via the EVD. Computed tomography was performed every 24 h and dosing was continued every 8 h until either 12 doses were given, the third and fourth ventricles were open, intraventricular mass effect was relieved, or 80% of clot volume was removed. As previous studies have suggested, the CLEAR III trial found intraventricular alteplase to be safe. In fact, use of alteplase was associated with a significantly lower rate of bacterial ventriculitis and serious adverse events compared to saline. Symptomatic bleeding was equivalent between both groups. Instances of neurological, respiratory, and sudden death were lower in the alteplase group. While these results suggest that intraventricular alteplase is safer than intraventricular saline, it is not necessarily safer than leaving an EVD in place without introducing any substances into it. Since intraventricular infusion of saline is not a typical intervention, the control in this study may not be exactly representative of risks associated with usual clinical practice. Nevertheless, as expected based on previous studies,2,5 the trial did not demonstrate a significant risk associated with use of intraventricular alteplase. Patients were evaluated by mRS, extended Glasgow Outcome Scale, Barthel index, Supports Intensity Scale, and National Institutes of Health Stroke Scale on days 7, 30, 180, and 365 following initial intervention. The primary outcome measure of intervention efficacy was number of patients with mRS of 3 or less at day 180, which was stratified by IVH volume and ICH location. Overall, there was no significant difference in this primary outcome with only 117 intervention patients and 110 placebo patients achieving an mRS of 3 or less by day 180 (P = .554; Figure). This lack of difference was maintained despite stratification for volume and location. While functional outcome was not improved by intraventricular alteplase, the intervention did confer a 50% decrease in odds of mortality (P = .004). With these results taken together, the study demonstrated that while patients receiving intraventricular alteplase were more likely to survive, they were more likely to do so with severe functional deficits. Indeed, in post hoc analysis, there was a significantly greater proportion of alteplase patients with mRS 5 than in the saline group (P = .007). This group of patients likely represented those patients who would have otherwise succumbed to their hemorrhage if intraventricular thrombolytics had not been used. The study further investigated the relationship between clearance of intraventricular blood and functional outcomes. Both more rapid and more complete clot evacuation was significantly related to both improved survival and functional outcome. This point is an interesting one. Given the fact that the alteplase group did experience greater and more rapid clearance, it would be presumed that the results would have transferred over to the primary outcome measure. However, the authors explain that only 82 patients (33%) in the alteplase group actually achieved 80% clearance of IVH prior to cessation of therapeutic intervention. Furthermore, complete removal of clot varied greatly in both cohorts based on the location of EVD catheter placement relative to clot burden and the number of catheters placed (1 vs 2), which were not standardized. Thus, it may be that the therapeutic endpoints prevented patients from maximally benefiting from the alteplase intervention.Figure.: Comparison of modified Rankin Scale (mRS) outcomes between saline and alteplase groups at 30 and 180 days. At 180 days, the alteplase group had a significantly smaller proportion of deceased patients (19% vs 30%; P = 0.004) and a significantly larger proportion of severely disabled (mRS 5) patients (17% vs 9%; P = 0.007) compared to the saline group. There was no significant difference between alteplase and saline in proportion of patients with good outcome (mRS ≤ 3) at 180 days (48% vs 46%; P = 0.477). Reprinted from The Lancet, Jan 9 2016 [epub ahead of print].4 Copyright 2017, with permission from Elsevier.Although the study does not present a quick and easy answer to treatment of IVH, it does provide an important direction to future investigation into the use of thrombolytics for IVH. The above finding that rapid and complete clearance of intraventricular blood is associated with better outcomes suggests that therapeutic endpoints of future studies should be aimed at these 2 issues. Studies can endeavor to ensure earlier intervention, and continuation of intervention until complete hematoma evacuation is achieved. Furthermore, this finding may spark more discussion about number, size, and location of EVD placement6 to ensure effective delivery of thrombolytics to areas of greatest clot burden. Overall, this study is a thought provoking one. In an attempt to address a practical issue, the study opens the doors to a discussion that is perhaps more of an ethical one than a medical one. There is a similar discussion that exists around the use of hemicraniectomy in stroke patients with large territory infarcts.7 Are life-preserving interventions justifiable if they are mostly preserving poor quality of life? In the end, this issue highlights the importance of communication and transparency regarding interventions and prognosis between care teams and patient decision makers." @default.
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• W2607887939 date "2017-04-21" @default.
• W2607887939 modified "2023-10-17" @default.
• W2607887939 title "Intraventricular Thrombolytics in Intraventricular Hemorrhage: Their Role is not so Clear" @default.
• W2607887939 cites W142034419 @default.
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• W2607887939 doi "https://doi.org/10.1093/neuros/nyx104" @default.
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