Hyperacute Stroke Treatment:
Inclusion and Exclusion Criteria
T-PA Benefit
• Odds ratio of favorable outcome if t-PA is
given:
– within 90 min of symptom onset= 2.81 (95%
CI, 1.75-4.50)
– Within 90 and 180 min of symptom onset=
1.55 (95% CI, 1.12-2.15)
– Community registry study SITS-ISTR:
frequency of favorable outcome is 56.3% (CI,
55.3-57%)
T-PA Benefit 3 to 4.5 hour
• Odds ratio of excellent outcome= 1.40
(95% CI, 1.05-1.85)
• ECASS III trial odds ratio mRS 0-1: odds
ratio 1.34 (95% CI, 1.02- 1.76)
T-pa Risk
• Major risk is intracerebral hemorrhage with
variable rates of occurrence 1.9% to 10%
• Risk of hemorrhage increases in proportion to
degree to which the protocol is not followed
• Angioedema estimated to occur between 1.3 –
5.1%
– More associated with angiotensin converting
enzyme inhibitor use
– Infarct involving the insular and frontal cortex
Inclusion Criteria for Intravenous t-PA
• Diagnosis of ischemic stroke causing
measurable neurological deficit
• Onset of symptoms < 3hours before
beginning treatment
– Onset time is defined as either the witnessed
onset of symptoms or the time last known
normal if symptom onset was not witnessed
• Aged > 18 years
Exclusion Criteria for Intravenous t-PA
• Significant head trauma or prior stroke in
previous 3 months
– Small stroke within 3 months may be
considered but should be included in risk
discussion with patient or family member
• Symptoms suggest subarachnoid
hemorrhage
• Arterial puncture at a noncompressible site
in previous 7 days
Exclusion Criteria for Intravenous t-PA
• History of previous intracerebral
hemorrhage
• Intracranial neoplasm, arteriovenous
malformation, aneurysm
• Recent intracranial or intraspinal surgery
• Elevated blood pressure (systolic >185 or
diastolic >110mm Hg)
Exclusion Criteria for Intravenous t-PA
• Active internal bleeding
• Acute bleeding diathesis, including but not limited to:
– Platelet count < 100,00/mm
– Heparin received within 48 hours, resulting in
abnormally elevated aPTT greater than the upper limit
of normal
– Current use of anticoagulant wit INR>1.7 or PT>15
seconds
– Current use of direct thrombin inhibitors or direct
factor Xa inhibitors with elevatd sensitive laboratory
tests(i.e. aPTT, INR, ECT, TT, or appropriate factor
Xa activity assays
Exclusion Criteria for Intravenous t-PA
• Blood glucose concentration <50 mg/dl
– Can correct and reassess patient NIHSS
• CT demonstrates multilobar infarction
(hypodensity> 1/3 cerebral hemisphere
Relative Exclusion Criteria for
Intravenous t-PA
• Only minor or rapidly improving symptoms (clearing
spontaneously)
• Pregnancy
• Seizure at onset with postictal residula neurological
impairments
• Major surgery or serious trauma within past 14 days
• Recent gastrointestinal or urinary tract hemorrhage
(within past 21 days)
• Recent acute myocardial infarction (within previous 3
months)
Relative Exclusion Criteria for
Intravenous t-PA
• Under some circumstances– with careful
consideration and weighing of risk to
benefit– patients may receive t-PA despite
1 or more relative contraindications.
Relative Exclusion Criteria for
Intravenous t-PA
• Patients without recent use of oral
anticoagulants or heparin, treatment with t-PA
can be initiated before coagulation test results
are back. Discontinue t-PA if exclusion criteria
are met.
• Patients without a history of thrombocytopenia,
treatment with t-PA can be initiated before
platelet count is back. Discontinue t-PA if
exclusion criteria are met.
Additional Inclusion Criteria for Intravenous
t-PA use between 3 and 4.5 hours
• Diagnosis of ischemic stroke causing a
measurable neurological deficit
• Symptom onset within 3 to 4.5 hours before
beginning treatment
Additional Relative Exclusion For t-PA
administration within 3 to 4.5 hours
•
•
•
•
Aged >80 years
Severe Stroke (NIHSS> 25)
Taking an oral anticoagulant regardless of INR
History of both diabetes and prior ischemic
stroke
Warning Signs for Significant
Hemorrhagic Transformation
•
•
•
•
Sudden onset of severe headache
Acute hypertension
Acute nausea or vomiting
Worsening neurological exam
• Discontinue t-PA infusion and obtain stat
CT non-contrast of brain
• Restart infusion if no bleed
Conclusions
Ischemic Stroke:
Get a complete history and present history
succinctly and accurately to tele-neurologist
Alert tele-neurologist of any concerns with
regard to patient care or t-PA administration
Keep Communication Lines Open