Presentation on theme: "Hyperacute Stroke Treatment: Inclusion and Exclusion Criteria."— Presentation transcript:
Hyperacute Stroke Treatment: Inclusion and Exclusion Criteria
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
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
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