I am totally missing what the hell is going on here, talking about hemorrhage and clots in the same study.
http://www.medpagetoday.com/MeetingCoverage/ISC/56271?xid=nl_mpt_DHE_2016-02-19&eun=g424561d0r
An ambitious trial to test a novel approach to treat intraventricular
hemorrhage failed its primary endpoint, which was a measure of
disability, but it did produce a "strong biologic signal" suggesting the
treatment can save lives and reduce overall disability.
Nonetheless, disappointment with the results was palpable as Daniel F. Hanley Jr., MD,
of Johns Hopkins University, told a press conference at the
International Stroke Conference here, "The fact is we failed and we
cannot reject that null hypothesis."
But
he and his colleagues learned important lessons that will, he said,
direct future efforts: the larger the clot, the better the outcome --
and most importantly, success depends on the amount of clot that is
evacuated with the threshold for benefit being about 85% of the clot and
"major benefit seen when 90% is evacuated."
For 10 years, Hanley has championed what seems like a counterintuitive approach: using a lytic drug to treat the aftermath of a hemorrhagic stroke and he had high hopes for a trial called CLEAR III or Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage.
The basic concept is that recovery from these devastating strokes
requires rapid evacuation of blood that pools and eventually clots in
the ventricles after the initial bleeding stops. One approach used by
neurosurgeons is to insert an endovascular drain in the hope that it
would relieve pressure by draining intracerebral fluid and possibly help
the blood to drain away. But Hanley said that process was slowed as the
blood clotted around the drain and impeded the process.
By introducing alteplase, Hanley theorized that the blood could flow freely thus rapidly evacuating the clot.
He and his colleagues enrolled 500 patients with severe intravascular
hemorrhage with small intracranial hemorrhage (ICH). He told MedPage Today that
this stroke subtype has a high mortality rate -- 50% -- and 80% of
survivors have a poor outcome with permanent disability. The patients
were randomized to low dose alteplase, 1 mg every 8 hours for a maximum
of 12 doses, or to saline delivered by catheter.
The
primary endpoint was functional improvement as measured by the modified
Rankin stroke scale, which was assessed at 30, 180 and 365 days. At 180
days, that measure failed to show significant improvement for the drug
versus placebo.
Other outcome measures, including the Glasgow Outcome Scale that
comprises hard endpoints such as mortality and vegetative state, did
suggest a benefit: a 10% reduction in mortality and a reduction in
bacterial infections, probably because the clot was evacuated more
quickly. By that measure, treating just 10 patients would prevent a
death or major disability.
"But that was not the measure we chose," Hanley said.
Neurosurgeon Issam A. Awad, MD,
of the University of Chicago and a co-investigator for CLEAR III, said
the most important takeaway was the finding that the catheter needs to
be placed in the clot to achieve maximum benefit. Neurosurgeons
traditionally have been wary of placing a catheter directly in the clot,
but the study provided evidence that this critical placement could
increase the amount of blood that is drawn off, thus improving
functional outcomes.
Hanley said that he is planning CLEAR IV but noted that he has not yet secured funding for such a trial.
Use the labels in the right column to find what you want. Or you can go thru them one by one, there are only 28,983 posts. Searching is done in the search box in upper left corner. I blog on anything to do with stroke.DO NOT DO ANYTHING SUGGESTED HERE AS I AM NOT MEDICALLY TRAINED, YOUR DOCTOR IS, LISTEN TO THEM. BUT I BET THEY DON'T KNOW HOW TO GET YOU 100% RECOVERED. I DON'T EITHER, BUT HAVE PLENTY OF QUESTIONS FOR YOUR DOCTOR TO ANSWER.
Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.
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