If this has positive results you do have plans to create a protocol on this AND deliver it to all 10 million yearly stroke survivors now and into the future? You don't? WHAT THE FUCK INCOMPETENT MENTORS AND SENIOR RESEARCHERS DO YOU HAVE?
Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial: Study protocol for a randomized controlled trial
Abstract
Rationale:
Aneurysmal
subarachnoid hemorrhage (SAH) has high morbidity and mortality. While
the primary injury results from the initial bleeding cannot currently be
influenced, secondary injury through vasospasm and delayed cerebral
ischemia worsens outcome and might be a target for interventions to
improve outcome. To date, beside the aneurysm treatment to prevent
re-bleeding and the administration of oral nimodipine, there is no
therapy available, so novel treatment concepts are needed. Evidence
suggests that inflammation contributes to delayed cerebral ischemia and
poor outcome in SAH. Some studies suggest a beneficial effect of
anti-inflammatory glucocorticoids, but there are no data from randomized
controlled trials examining the efficacy of glucocorticoids. Therefore,
current guidelines do not recommend the use of glucocorticoids in SAH.
Aim:
The
Fight INflammation to Improve outcome after aneurysmal Subarachnoid
HEmorRhage (FINISHER) trial aims to determine whether dexamethasone
improves outcome in a clinically relevant endpoint in SAH patients.
Methods and design:
FINISHER
is a multicenter, prospective, randomized, double-blinded,
placebo-controlled clinical phase III trial which is testing the outcome
and safety of anti-inflammatory treatment with dexamethasone in SAH
patients.
Sample size estimates:
In
all, 334 patients will be randomized to either dexamethasone or placebo
within 48 h after SAH. The dexamethasone dose is 8 mg tds for days 1–7
and then 8 mg od for days 8–21.
Study outcome:
The
primary outcome is the modified Rankin Scale (mRS) at 6 months, which
is dichotomized to favorable (mRS 0–3) versus unfavorable (mRS 4–6).
Discussion:
The results of this study will provide the first phase III evidence as to whether dexamethasone improves outcome in SAH.
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