Presentation on theme: "Hyperacute Stroke Treatment: Inclusion and Exclusion Criteria"— Presentation transcript:
1Hyperacute Stroke Treatment: Inclusion and Exclusion Criteria
2T-PA Benefit Odds ratio of favorable outcome if t-PA is given: within 90 min of symptom onset= 2.81 (95% CI, )Within 90 and 180 min of symptom onset= 1.55 (95% CI, )Community registry study SITS-ISTR: frequency of favorable outcome is 56.3% (CI, %)
3T-PA Benefit 3 to 4.5 hourOdds ratio of excellent outcome= 1.40 (95% CI, )ECASS III trial odds ratio mRS 0-1: odds ratio 1.34 (95% CI, )
4T-pa RiskMajor 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 followedAngioedema estimated to occur between 1.3 – 5.1%More associated with angiotensin converting enzyme inhibitor useInfarct involving the insular and frontal cortex
5Inclusion Criteria for Intravenous t-PA Diagnosis of ischemic stroke causing measurable neurological deficitOnset of symptoms < 3hours before beginning treatmentOnset time is defined as either the witnessed onset of symptoms or the time last known normal if symptom onset was not witnessedAged > 18 years
6Exclusion Criteria for Intravenous t-PA Significant head trauma or prior stroke in previous 3 monthsSmall stroke within 3 months may be considered but should be included in risk discussion with patient or family memberSymptoms suggest subarachnoid hemorrhageArterial puncture at a noncompressible site in previous 7 days
7Exclusion Criteria for Intravenous t-PA History of previous intracerebral hemorrhageIntracranial neoplasm, arteriovenous malformation, aneurysmRecent intracranial or intraspinal surgeryElevated blood pressure (systolic >185 or diastolic >110mm Hg)
8Exclusion Criteria for Intravenous t-PA Active internal bleedingAcute bleeding diathesis, including but not limited to:Platelet count < 100,00/mmHeparin received within 48 hours, resulting in abnormally elevated aPTT greater than the upper limit of normalCurrent use of anticoagulant wit INR>1.7 or PT>15 secondsCurrent 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
10Relative Exclusion Criteria for Intravenous t-PA Only minor or rapidly improving symptoms (clearing spontaneously)PregnancySeizure at onset with postictal residula neurological impairmentsMajor surgery or serious trauma within past 14 daysRecent gastrointestinal or urinary tract hemorrhage (within past 21 days)Recent acute myocardial infarction (within previous 3 months)
11Relative 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.
12Relative 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.
13Additional Inclusion Criteria for Intravenous t-PA use between 3 and 4 Additional Inclusion Criteria for Intravenous t-PA use between 3 and 4.5 hoursDiagnosis of ischemic stroke causing a measurable neurological deficitSymptom onset within 3 to 4.5 hours before beginning treatment
14Additional Relative Exclusion For t-PA administration within 3 to 4 Additional Relative Exclusion For t-PA administration within 3 to 4.5 hoursAged >80 yearsSevere Stroke (NIHSS> 25)Taking an oral anticoagulant regardless of INRHistory of both diabetes and prior ischemic stroke
15Warning Signs for Significant Hemorrhagic Transformation Sudden onset of severe headacheAcute hypertensionAcute nausea or vomitingWorsening neurological examDiscontinue t-PA infusion and obtain stat CT non-contrast of brainRestart infusion if no bleed
16Conclusions Ischemic Stroke: Get a complete history and present history succinctly and accurately to tele-neurologistAlert tele-neurologist of any concerns with regard to patient care or t-PA administrationKeep Communication Lines Open