Professional organizations support treatment with Activase (t-PA)

Guidelines and consensus statements on the use of Activase (t-PA) in acute ischemic stroke

  • Practice guidelines and policy statements* by many professional organizations dedicated to improving patient outcomes support Activase (t-PA) use:
    • – Within 3 hours of eligible patients exhibiting signs and symptoms of acute ischemic stroke
  • *
  • Note: Each of these guidelines or policy statements represents only one possible approach to the treatment of eligible acute ischemic stroke patients. Each healthcare practitioner and institution will need to exercise professional judgment in creating or adopting treatment protocols or guidelines, as well as in the treatment of each individual patient.

Genentech is neither affiliated with nor endorses any of the following organizations.

American Heart Association/American Stroke Association (AHA/ASA)

  • The 2007 American Heart Association (AHA)/American Stroke Association (ASA) Guidelines for the Early Management of Adults With Ischemic Stroke continues to give Activase (t-PA) its strongest recommendation (Class I, Level of Evidence A)1†
  • †
  • Class I = conditions for which there is evidence for and/or general agreement that the procedure or treatment is useful and effective; Level of Evidence A = data derived from multiple randomized clinical trials.

American Academy of Neurology (AAN)

  • The AAN, in its Practice Advisory: Thrombolytic Therapy for Acute Ischemic Stroke, supports administration of Activase (t-PA) within FDA-approved labeling2

American College of Emergency Physicians (ACEP)

  • The ACEP, in its policy statement, Use of Intravenous tPA for the Management of Acute Stroke in the Emergency Department, notes that IV t-PA may be efficacious in the management of acute ischemic stroke if used properly and when incorporating guidelines that were established by the National Institute of Neurological Disorders and Stroke (NINDS)3

Brain Attack Coalition (BAC)

  • The BAC,‡ in its 2005 consensus statement, Recommendations for Comprehensive Stroke Centers, recommends lytics as a component of a Comprehensive Stroke Center (CSC)§ (grade IIB)4∥
  • ‡
  • The Brain Attack Coalition (BAC) is a multidisciplinary group of members from major professional organizations involved with the care of patients with stroke and cerebrovascular disease.
  • §
  • A comprehensive stroke center (CSC) is defined as a facility or system with the necessary personnel, infrastructure, expertise, and programs to diagnose and treat stroke patients who require a high intensity of medical and surgical care, specialized tests, or interventional therapies. Such patients include, but are not limited to, patients with ischemic stroke.
  • ∥
  • Supported by level II evidence: data from randomized, controlled trial (RCT), but may have false positives or negatives; may not be FDA-approved, but therapy (Rx) is widely or commonly used in many medical centers.

Society for Academic Emergency Medicine (SAEM)

  • The Society for Academic Emergency Medicine endorses the creation of national research initiatives, including a registry to gather outcomes data for stroke victims, whether or not thrombolytic therapy is administered. Data should include details of the care process, including timeliness and quality of the clinical interventions and adequacy of important support systems. At this time, decisions regarding thrombolytic therapy must be individualized, based on specific clinical and operational circumstances5

National Association of EMS Physicians (NAEMSP)

  • The National Association of EMS Physicians, in its position paper of 2000, stated that EMS medical directors should be aware of available local stroke treatment options, including experimental treatments6

Indication: Activase is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS in the full prescribing information).

Safety Information: All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in appropriate patients. Not all patients with acute ischemic stroke will be eligible for Activase therapy, including patients with evidence of recent or active bleeding; recent (within 3 months) intracranial or intraspinal surgery, serious head trauma, or previous stroke; uncontrolled high blood pressure; or impaired blood clotting.


Please see full prescribing information.


References:
1.
Adams HP Jr, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Stroke. 2007;38:1655-1711.
2.
American Academy of Neurology (AAN) Practice Advisory: Thrombolytic Therapy for Acute Ischemic Stroke (Summary Statement). 1996.
3.
American College of Emergency Physicians (ACEP) Position Statement. February 2002.
4.
Alberts MJ, Latchaw RE, Selman WR, et al, for the Brain Attack Coalition. Recommendations for comprehensive stroke centers: a consensus statement from the Brain Attack Coalition. Stroke. 2005;36;1597-1616.
5.
Society for Academic Emergency Medicine position statement. Optimizing care of the stroke patient. January 2003.
6.
Sahni R, for the National Association of EMS Physicians Standards and Clinical Practice Committee. Acute stroke: implications for prehospital care. Prehosp Emerg Care. 2000;4:270-272.
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