Ah, the CLEAR trial – a trial evaluating the efficacy of intraventricular injections of alteplase for intracerebral hemorrhage with acute obstructive hydrocephalus. In other words, treating brain bleeds with an agent responsible for brain bleeds. It is not quite as nonsensical as it seems, however, as improved resolution of the intraventricular blood is linked to improved outcomes.
This trial, however, performed over the course of six years and enrolling 500 patients, fails to find anything reliable in favor of alteplase – a rather inconsequential end to a decade’s worth of build-up from the initial and phase II trial. At the end of the day, there was no significant difference between either treatment with regard to the primary outcome, patients attaining a mRS of 0-3.
It should also be noted the preliminary results from this trial were presented last year at the International Stroke Conference with breathless coverage:
“CLEAR III: tPA Clot Removal Hope for Intraventricular Hemorrhage”
Along with the lead author stating “This treatment saves lives. Our results suggest that physicians should begin to think about using it for stable hemorrhagic stroke patients.”
Which, now that we can all review the results together, is obviously not the case – nor is it their conclusion in the published article. These results do raise some questions – mortality was lower in the intervention group, and patients with improve clot evacuation also tended to do better – regarding potential subgroups for benefit. However, without further prospective data to confirm these signals, this intervention should continue to be reserved for controlled trials.
“Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial”
https://www.ncbi.nlm.nih.gov/pubmed/28081952