Deans' stroke musings: Prospective, open-label safety study of intravenous rtPA in wake-up stroke

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.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Saturday, June 25, 2016

Prospective, open-label safety study of intravenous rtPA in wake-up stroke

They don't bother to tell us the full recovery rate at all to see if it is any better than the current tPA only fully working 12% of the time?
http://www.ncbi.nlm.nih.gov/pubmed/27273860

Barreto AD¹, Fanale CV², Alexandrov AV³, Gaffney KC⁴, Vahidy FS¹, Nguyen CB⁵, Sarraj A¹, Rahbar M^6,^7,⁸, Grotta JC⁹, Savitz SI¹; Wake-Up Stroke Investigators..

Author information

Abstract

OBJECTIVE:

It is estimated that 1 of 4 ischemic strokes are noticed upon awakening and are not candidates for intravenous recombinant tissue plasminogen activator (rtPA) because their symptoms are >3 hours from last seen normal (LSN). We tested the safety of rtPA in a multicenter, single-arm, prospective, open-label study (NCT01183533) in patients with wake-up stroke (WUS).

METHODS:

We aimed to enroll 40 WUS patients with disabling deficits. Patients were 18-80; NIHSS ≤25; and selected only on the appearance of non-contrast CT (i.e., <1/3 MCA territory hypodensity). Standard dose (0.9mg/kg) intravenous rtPA had to be started ≤3 hours of patient awakening. The primary safety outcome was symptomatic intracerebral hemorrhage (sICH) with pre-planned stopping rules and data safety board oversight. Other endpoints included: asymptomatic ICH, clinical improvement in NIHSS and 90-day modified Rankin Scale score (mRS).

RESULTS:

Between 10/2010 and 10/2013, all 40 pre-planned patients were enrolled (50% men) at 5 stroke centers. Four patients (10%) were subsequently determined to be mimics. Patients had a mean age of 60.8, median NIHSS of 6.5 (2-24 range) and received thrombolysis at a mean time of 10.3 ± 2.6 LSN and 2.6 ± 0.6 hours from awakening with deficits. No sICH or parenchymal hematomas occurred. At 3-months, 20 of 38 (52.6%) patients achieved excellent recovery with modified Rankin scale scores of 0 or 1 (2 patients were lost to follow-up).

INTERPRETATION:

Intravenous thrombolysis was safe in this prospective WUS study of patients selected by non-contrast CT. A randomized effectiveness trial appears feasible using a similar, pragmatic design.