DOWNTIME
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downtime
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INTRAVENOUS TISSUE PLASMINOGEN
ACTIVATOR FOR STROKE 3-4.5 HOURS
ADMINISTRATION CONSENT
Patient Name
Date of Birth
Admission/Visit Date
Medical Record Number
Site
Financial Number
Patient ID Area
I understand that my doctor
believes that I
have suffered a stroke. I also believe that I may benefit from treatment of intravenous (IV) tissue
plasminogen activator (tPA). tPA is a medication that dissolves blood clots. It is an intravenous (IV)
medication usually given through a catheter into a vein.
tPA is only approved by the Federal Drug Administration (FDA) to be given intravenously within three
(3) hours of stroke symptom onset. According to the National Institute of Neurological Disease and
Stroke (NINDS) study published in 1995, patients receiving tPA have a 30 percent better chance,
three months after stroke, of having minimal or no disability. IV tPA given within 3 hours of stroke
onset is the most effective acute stroke treatment available.
Based on further recent medical study* in May of 2009, the American Heart Association (AHA)
Stroke Council recommended in its guideline for acute treatment of ischemic stroke extension of the
window of treatment with IV tPA up to four and one-half (4.5) hours of stroke symptom onset. The
study demonstrated that patients receiving tPA within this period of time also had a better chance of
no or minimal disability, and a more favorable outcome, three months after stroke, when compared
to patients that had not received treatment.
I understand that IV tPA treatment has risks. The same study indicated an approximate 2.4 to 7.9
percent chance of brain hemorrhage in patients receiving tPA at 3 to 4.5 hours as compared to
approximately 0.2 to 3.5 percent of patients not receiving this treatment. Brain hemorrhage, if it
occurs, can result in a significant worsening of my stroke symptoms, may increase my ultimate
disability, and may even cause my death. For 1 out of 6 persons treated, tPA may cause death or
long term serious disability. At this time, the FDA has not changed its indication of use for IV tPA to
this expanded period of time.
Alternative treatment options to this therapy are 1) No Treatment 2) Possible participation in an
investigational protocol (study) 3) Endovascular treatment if indicated without tPA, among others
my doctor may discuss with me. These options have been explained to me to my satisfaction.
I have read the above information and consent to the administration of tPA therapy as described
above. The risks and benefits of this treatment for my condition have been explained to me by my
treating physician(s) and I have been able to ask and receive the answers to any questions I have
had.
Date
Time
Physician Signature
Date
Time
Patient/Legal Representative Signature
Date
Time
Witness Signature
* del Zoppo G, Saver J, Jauch ED, et al. Expansion of the Time Window for Treatment of Acute Ischemic Stroke with Intravenous
Plasminogen Activator. A Science Advisory from the American Heart Association Stroke Association. Stroke 2009; 40: 2945.
KH01338 Rev. 06/22/10
CONSENT