The New Jersey Acute Stroke Registry (njasr), Version 1 Data Collection Manual Effective Date: January 1, 2014 Last Revised Date: October 1, 2016

80. 
    Are there documented Exclusions (Contraindications) or Relative Exclusions (Warnings) for not initiating IV Thrombolytic in the 3 – 4.5 hr treatment window: [ContraWarn2]
    

1 = Yes

No: There is no documentation of a reason for not initiating IV thrombolytic, OR unable to determine from the medical record documentation.

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  In order to select the additional warnings, the reasons for no IV tPA must be explicitly documented in the context of the 3-4.5 hour treatment window (i.e., the physician documented “no IV tPA after 3 hours of symptom onset due to patient age 90”, Select “Age>80”.
  

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  Reasons for not initiating IV thrombolytic therapy must be documented by a physician/APN/PA or pharmacist with three exceptions: Patient/family refusal, NIHSS score of zero, and initiation of IV or IA thrombolytic at a transferring hospital. These three exceptions may be documented by a nurse. Reason documentation must refer to the timeframe for thrombolytic therapy.
  

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  If reasons are not mentioned in the context of IV thrombolytics, do not make inferences (e.g., do not assume that IV thrombolytic was not initiated because of a bleeding disorder unless documentation explicitly states so).
  

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  Documentation of the initiation of IV or IA thrombolytic at a transferring hospital is a stand-alone reason and sufficient to meet the intent of this data element, even if IV tPA was started at an outside hospital, and infusion continued after patient arrives at your facility. No further documentation of it as the reason for not initiating IV t-PA at this hospital is needed.
  

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  If documentation indicates a National Institute of Health Stroke Scale (NIHSS) score of zero, select “Yes”. Score documentation must refer to the timeframe for thrombolytic therapy. No linking statement is needed here to indicate “stroke severity too mild” as a relative exclusion.
  

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  Do not document evidence from outside the physician, or nurse notes that played a factor in the decision-making process for not giving thrombolytic therapy. EXCEPTION: If your hospital uses telemedicine in assessing stroke patients, it is acceptable to select reasons specified by the teleneurologist when reasons are documented in the medical record. In these cases, it is acceptable for the documentation to be done by a nurse.
  

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  It is permissible to abstract reasons for non-treatment from the medical record that are documented after the IV tPA treatment decision has been made as long as the documentation is made prior to patient discharge (addendums cannot be made after discharge). Documented reason must refer to the timeframe for thrombolytic therapy
  

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  “Care team unable to determine eligibility” means that the diagnosis of stroke was made but that eligibility for thrombolytic therapy could not be established or the clinician could not verify the patient’s eligibility for treatment. The most common reason for this is that the time of onset could not be clearly established at the time of patient assessment in the ED. It can also arise when the timing of a recent procedure or surgery could not be definitely established, or time of last known well (LKW) is unknown. If unable to determine the time last known well, please select “unknown” for the time last known well field.
  

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  If the patient is on anticoagulants (Warfarin, Coumadin) and this is documented as the reason for not administering IV thrombolytics, and the PT, PTT, or INR is elevated, select Exclusion Criteria “Acute bleeding diathesis”.
  

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  Conditions that increase the risk of bleeding or decrease the benefit of treatment to the individual patient must be explicitly listed in the medical record and documented as being the reason that thrombolytics were not used. Conditions may include: Acute pericarditis, SBE (spontaneous bacterial endocarditis), Hemostatic defects, Diabetic hemorrhagic retinopathy, Septic thrombophlebitis, occluded AV cannula, or patient is currently receiving oral anticoagulants (e.g., Warfarin, therapeutic dose of dabigatran (Pradaxa).
  

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  Advanced age alone is no longer considered a sufficient reason for not providing tPA in the 0-3 hour window. There is sufficient evidence from subgroup analysis of the randomized trials to conclude that beneficial effects of tPA are seen in advanced age when patients are treated with 0-3 hours, and the Scientific Rationale 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 recommends treatment of elderly ischemic stroke patients who meet other criteria, without restriction by age. There is no specific upper age limit on the use of IV tPA. However, the prevalence of other exclusions or relative exclusions to treatment (e.g. other illnesses that reduce life expectancy to <1 year) may be higher in patients with very advanced age, reducing the number of elderly patients who may be eligible for tPA treatment. For patients at 3-4.5 hours, age >80 remains a relative exclusion because such patients were not included in the randomized controlled trial.
  

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  Select "Life expectancy < 1 year or severe co-morbid illness or CMO on admission" if the patient has an order for Comfort Measures Only in the ED and this restriction of care preceded evaluation for IV tPA. This option is also appropriate when patients are not treated due to coexisting terminal cancer, advanced dementia, severe cardiopulmonary disease or other conditions which severely limit quality of life or life expectancy. Limited life expectancy, severe co-morbid conditions, and CMO status all need to be explicitly documented as the reason for no IV tPA. Do not make inferences.
  

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  Select "Rapid improvement" or "Stroke severity too mild" when symptoms are rapidly improving or there is minimal to no disability associated with the stroke symptoms (e.g. numbness, mild weakness, lack of gait impairment). Note that there is no lower limit to NIHSS score that prohibits the use of IV tPA.