Wednesday, January 20, 2016

AHA / ASA Scientific statement re exclusion/inclusion criteria for alteplase


 
Demaerschalk BM, Kleindorfer DO, Adeoye OM, et al.  AHA/ASA Scientific statement  for the inclusion and exclusion criteria for intravenous alteplase in acute ischemic stroke: a statement for healthcare professionals from the American Heart Association/ American Stroke Association.  Stroke 2016; 47:  1-61.
The above article was previously circulated .  It is not a practice parameter.   It functions as an FAQ / legal cover/ resource for many uncommon scenarios for stroke alerts.  It is not ORMC policy to abide by it.  However, it does summarize existing evidence well, and assigns a grade to the quality of the evidence (class/level of evidence) grades that have become popular. I am re-presenting it in tabular form so it is available during stroke alerts, if needed. 
Please circulate to any/all additional members of the team involved in stroke care that might wish to see it.  Thanks
Daniel Jacobs, MD, FAAN
Director , Orlando Health  Comprehensive Stroke Center
 
Zero to -3 hour window
Not an exclusion
1.  Age > 80
2.  severe stroke
3.  mild / rapidly improving but still disabling stroke
4.  coagulation studies not returned but no clinical suspicion of bleeding disorder 
warfarin use if INR is lower than OR EQUAL to 1.7
5. MI within three months if the MI was nSTEMI, or STEMI affecting the right or inferior myocardium
6.  GI/GU bleed more than 21 days ago
7.  History of cerebral microbleeds
8.  Unruptured cerebral aneurysm (unless a giant aneurysm)
9.  Intracranial extraaxial neoplasm
10. End stage renal disease with normal PTT
11.  Seizure at stroke onset  unless deficits are suspected to be due to postictal phenomenon
12.  Suspected extracranial cervical arterial dissection
13.  Lumbar puncture within 7 days
14. Post cerebral or cardiac catheterization related acute stroke
15.  Absent person to consent for an otherwise eligible patient
16.  Single or dual antiplatelet therapy
17.  Cocaine or other drug use as a possible cause of stroke
alteplase can be considered if benefits outweigh risks
1.  pregnancy esp moderate to severe deficit
2.  history of bleeding diathesis including renal or hepatic disease (consider on a case by case basis)
3.  use of NOAC's (novel anticoagulants) > 48 hours if renal dysfunction is present,may assess with lab (PT, PTT, platelet count, ecarin clotting time, thrombin time, or direct factor Xa activity) 
4.  Major surgery within 14 days- with careful selection and weighing the risk of hemorrhage at the site
5. Major trauma within 14 days on a case by case basis
6.  MI affecting the left anterior myocardium
7. Pericarditis with severe deficit after consulting a cardiologist
8. LV or LA thrombus with severe stroke likely to cause severe disability
9. History of recent stroke within three months
10.  Uncontrolled severe HTN > 185/110 unless it can be lowered safely in a stable fasion and monitored and kept low for 24 hours.
11. Dementia considering premorbid function, patient and family wishes and goals of therapy
12.  Current malignancy if no other contraindications and reasonable life expectancy (> 6 months)
13.  Preexisting major disability considering premorbid function, family wishes and goals of therapy
14.  Diabetic hemorrhagic retinopathy weighing and presenting risks of visual loss against stroke deficit
15.  Vaginal bleeding including menstruation that is monitored for 24 hour period; if anemia is present consider consulting GYN first
16.  Cardiac myxoma and large severe deficit; same for papillary fibroelastoma
Absolute exclusion, uncertain benefit or no evidence favoring
1.  acute intracranial hemorrhage on CT scan
2.  warfarin use with INR > 1.7
3.  therapeutic or prophylactic low molecular weight heparin dose within 24 hours
 or use of NOAC's (novel anticoagulants) within 48 hours  unless lab parameters as appropriate are assessed
4.  Major head trauma within three months
5.  Posttraumatic infarction that occurs in the hospital
6. Pericarditis with mild deficit
7.  LA or LV thrombus with expected mild or moderate disability
8.  Infective endocarditis
9.  Intracranial or intraspinal surgery within three months
10. Major GI or GU bleed within 21 days
11.  Arterial puncture of a noncompressible site within 7 days (eg. subclavian artery)
12. History of intracranial hemorrhage
13. Unruptured cerebral giant aneurysm
14.  Unruptured untreated cerebral AVM's unless benefit outweighs the heightened risk
15.  Intracranial neoplasm intraaxial
16.   End stage renal disease with elevated PTT
17.  Blood glucose initially < 50 or > 400 unless corrected
18.  Large area of hypoattenuation on initial CT scan
19.  Clinical suspicion of subarachnoid hemorrhage
20.  Suspected aortic arch dissection
21.  Suspected intracranial dissection
22.  Stroke due to sickle cell disease
Extended window:  Three to 4.5 hours
Not an exclusion
1.  Age > 80
2.  On warfarin with INR < 1.7
3.  Prior stroke and diabetes
alteplase can be considered if benefits outweigh risks
Absolute exclusion, uncertain benefit or no evidence favoring
1.  NIHSS > 25
2.  Wake up stroke with time last normal > 4.5 hours
3.  Use of neuroimaging to select patients with last time normal > 4.5 hours

Sunday, January 03, 2016

Alteplase in strokes with NIHSS>25

Mazya MV, Lees KR, Collas D, et al.  IV thrombolysis in very severe and severe acute ischemic stroke. Results from the SITS/ISTR registry.  Neurology 2015; 85:20898-2106 (also editorial).
 
Authors study a large number of patients with severe strokes and find that iv alteplase does not affect their chances of developing a hemorrhage.  There also was no difference in treatment benefit compared to those with lower NIHSS scores.