Table 1.
Contraindications and Warnings to IV rtPA use.
| Clinical variable | Activase Insert | 2007 AHA / ASA Guidelines | 2013 AHA / ASA Guidelines | Observations |
|---|---|---|---|---|
| Time from symptom onset > 3 hours | ✓ | ✓ | ||
| Time from symptom onset > 4.5 hours | ✓ | |||
| 3 to 4.5 hours from symptom onset: | ✓ | The benefit of IV rTPA in the presence of one or more of these criteria is not well established | ||
| Age > 80 years (a) | ✓ | |||
| Any oral anticoagulant use (a) | ✓ | |||
| NIHSS > 25 (a) | ✓ | |||
| History of stroke and diabetes (a) | ✓ | |||
| Imaging evidence of ischemic injury > 1/3 of MCA territory | ✓ | |||
| Presence of intracranial hemorrhage | ✓ | ✓ | ✓ | |
| Suspicion of subarachnoid hemorrhage | ✓ | ✓ | ✓ | |
| Serious head trauma / stroke < 3 months | ✓ | ✓ | ✓ | Guidelines obviate the word “serious” |
| Recent intracranial, intraspinal surgery | ✓ | ✓ | Less than 3 months in the insert. | |
| Myocardial infarction < 3 months | ✓ | RC | ||
| Recent GI or urinary tract hemorrhage | W | ✓ | RC | Guidelines suggest < 21 days |
| Recent major surgery | W | ✓ | RC | Guidelines suggest < 14 days |
| Recent arterial puncture at a non-compressible site | W | ✓ | ✓ | Guidelines suggest < 7 days |
| History of intracranial hemorrhage | ✓ | ✓ | ✓ | |
| Uncontrolled hypertension | ✓ | ✓ | ✓ | >185 mm Hg systolic or > 110 mm Hg diastolic |
| Seizure at the onset of symptoms | ✓ | RC | RC | |
| Active internal bleeding | ✓ | ✓ | ✓ | |
| Intracranial neoplasm or AVM | ✓ | ✓ | Known presence of neoplasm or AVM. Brain imaging with contrast or angiography are not required prior to IV rTPA | |
| Intracranial aneurysm | ✓ | ✓ | ||
| Current use of oral anticoagulants irrespective of INR | ✓ | Guidelines allow IV rTPA while on warfarin therapy if INR is <1.7. | ||
| INR > 1.7 or PT > 15 seconds | ✓ | ✓ | ✓ | |
| Heparin < 48 hours and prolonged aPTT | ✓ | ✓ | ✓ | |
| Platelet count < 100'000/mm3 | ✓ | ✓ | ✓ | |
| Use of novel oral anticoagulants and abnormal coagulation tests | N/A | N/A | ✓ | Coagulation tests include aPTT, INR, platelet count, and ECT; TT; or factor Xa activity assay |
| Conditions where bleeding constitutes a significant hazard or would be particularly difficult to manage due to its location (b) | W | |||
| Acute trauma (fracture) | W | ✓ | RC | |
| Minor and isolated neurological deficits or spontaneously clearing symptoms | W | ✓ | RC | |
| Major deficits or NIHSS > 22 | W | W | ||
| Major early infarct signs on CT scan | W | ✓ | ✓ | Guidelines suggest a CT scan with hypodensity > 1/3 of cerebral hemisphere |
| Glucose < 50 mg/dl or > 400 mg/dl | W | ✓ | ✓ | Guidelines do not mention a higher glucose value |
| Pregnancy | W | RC | ||
| Advanced age (e.g., over 75 years) | W | |||
| Cerebrovascular disease | W | Not a warning in clinical practice | ||
| High likelihood of left atrial heart thrombus (e.g. mitral stenosis with atrial fibrillation) | W | Variable is likely very rare and was not included in survey. | ||
| Septic thrombophlebitis or occluded AV cannula at seriously infected site | W | Variable is likely very rare and was not included in survey. | ||
Criterion present in the 2009 AHA Science Advisory
This includes acute pericarditis, subacute bacterial endocarditis, hemostatic defects, significant hepatic dysfunction, diabetic hemorrhagic retinopathy, and other hemorrhagic ophthalmic conditions.
W = Warning, RC = Relative contraindication, INR = International Normalized Ratio, PT = Prothrombin Time, aPTT = Activated partial thromboplastin time, CT = computerized cranial tomography, AHA = American Heart Association, ASA = American Stroke Association, NSTEMI = Non ST segment elevation myocardial infarction, STEMI = ST segment elevation myocardial infarction, AVM = Arterio-venous malformation, GI = Gastrointestinal, ECT = Ecarin clotting time, TT = Thrombin time.