s
TPA and Appropriate documentation for
contraindications: A conversation with
The Joint Commission and a Physician
Perspective
Shyam Prabhakaran, MD, MS
Rush University Medical Center
11/7/08
s
Acute Stroke Care
• Rapid, accurate
assessment
• Imaging protocols
• Guideline based order
sets, protocols, and
pathways
• Quality and outcome
monitoring
Source: JAMA, 2000;283:3102-3109 Recommendations for the Establishment of Primary Stroke Centers
s
DSC/Stroke-4: Tissue Plasminogen
Activator (t-PA) Considered
Measure: All patients who present at a
hospital with symptoms of an ischemic
stroke with symptom onset of 3 hours or
less should be considered to receive
intravenous (IV) t-PA
Rationale: The administration of
thrombolytic agents to carefully screened,
eligible patients with acute ischemic stroke
has been shown to be beneficial in some
recent clinical trials. IV t-PA is the only
FDA approved treatment for acute
ischemic stroke.
s
Acute Stroke Evaluation:
60 Minute or Less Protocol
• Triage – 10 minutes: Patient compliant, focused history,
vital signs, GCS, ECG
• ED Physician – 10 to 20 minutes: Focused history and
physical exam, laboratories, CT Scan-codes stroke
(Goal: 25 minute door-to-CT)
– Vital sign monitoring, neurologic checks, seizure and aspiration
precautions
• Neurology Consult – 20-30 minutes: Review history,
physical exam, review CT Scan
• Treatment Decisions
s
Time is Brain
=
Stroke Onset to
IV TPA < 3 hours
Door to IV TPA Goal < 60 Minutes
• STARS Registry
– 38 community, 18 academic hospitals, 389 IV TPA pts
– Median door to needle time: 96 minutes
• CDC 4 State Pilot Acute Stroke Registry
– 98 hospitals, 6867 acute patients, 118 IV TPA
– Treatment within target 60 minutes: 14.4%
s
Differential Diagnosis
•
•
•
•
•
Ischemic Stroke
Hemorrhagic Stroke
Trauma
Meningitis/Encephalitis
Mass
– tumor
– subdural hematoma
• Seizure: post-ictal
• Metabolic
– hyperglycemia
– hypoglycemia
– post-cardiac arrest
– drug overdose
s
CT Results
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Strategies in Acute Ischemic Stroke
• Proven
– Supportive Care:
–
–
–
–
Treat hypoxia
Maintain normothermia
Avoid hyperglycemia
Early parental fluids and permissive hypertension
– Recanalization (Thrombolytics < 3 hours)
– Prevent Clot Propagation
– Early Implementation of Secondary Prevention
s
NIH/NINDS tPA study
Design
Randomized, double-blind placebo-controlled trial
Raters different from baseline examiners
Two parts
Part 1: 24-hour improvement
• Complete resolution of deficit or improvement of 4 points on the
NIH stroke scale
Part 2: 3-month outcome
• Consistent and persuasive difference in proportion of patients with
minimal or no deficit
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Eligibility Criteria
• Ischemic stroke with clearly defined
time of onset < 3 hours
• Baseline CT negative for hemorrhage
• Age > 18 years
• Moderate to severe symptoms
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Treatment
Dose
0.9 mg/kg (maximum 90 mg)
10% given as IV bolus
90% constant IV infusion over over 1 hr
Other meds No other anticoagulants or antiplatelet
agents for 24 hours post tPA
Strict BP control (< 180/105 mmHg)
post-tPA
s
Thrombolytic Therapy Checklist
• >18 y.o. with ischemic stroke < 3 hours
• Moderate or severe symptoms
• Coagulation status
– If patient has received recent anticoagulation therapy: PT
< 15 sec. and normal PTT
– Platelets > 100,000
• Blood Pressure SBP<185mmHg, DBP <110
• Glucose > 50 mg/dl
Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:1056-1083.
s
Other exclusion criteria
• Prior stroke or head trauma
within 3 months
• Rapidly improving or mild
symptoms
• Major surgery within 14 days
• Seizure at stroke onset
• History of ICH or SAH
• SBP > 185 or DBP > 110
• GI or GU hemorrhage within
21 days
• Glucose <50 or >400 mg/dL
• Arterial puncture at noncompressible site within 7 days
• Elevated PT > 15s or PTT >
1.5x normal
• Lumbar puncture within 7
days
• Platelet count < 100,000
• Any oral anticoagulants
s
NINDS TPA Stroke Trial
Excellent outcome at 3 months on all scales
60%
52%
50%
40%
38%
43%
45%
31%
30%
26%
34%
21%
20%
10%
0%
Barthel
Index
Rankin
Scale
Glasgow
Outcome
NIHSS
score
Global outcome statistic: OR=1.7, 50% v. 38%= 12% benefit
TPA
Placebo
s
•
Benefit at 3 months
– 55% more likely to be neurologically
normal
• 12% absolute benefit
• NNT is 8
– 60-70% more likely to have favorable
outcome
• Risk of sICH is 6.4%
– Overall benefits include ICHs
Adams HP Jr. Stroke 2003;34:1056-1083.
s
Number Needed to Treat to Benefit from IV TPA
Across Full Range of Functional Outcomes
Outcome
Normal/Near Normal
Improved
NNT
8.3
3.1
For every 100 patients treated with tPA,
32 benefit, 3 harmed
Stroke 2007; 38:2279-2283
s
Marler JR et al. Neurology 2000;55:1649-55.
s
Use of tPA in Routine Clinical Practice
• Efficacy similar to NINDS trial
• Rate of ICH: 4%-6%
• Risk of ICH increases with protocol violations
–
–
–
–
Time >3 hours
Poor blood pressure control
Using prohibited agents
Wrong dose
• 0.9 mg/kg
• Maximum dose: 90 mg
– Elevated blood sugar also increases risk
Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:1056-1083.
s
• Only 1.8-2.4% of stroke patients review IV tPA
• Reasons for exclusions
– Delayed patient arrival (>3 hrs)
– In-hospital delays in completion of required tests prior
to rt-PA administration
– Presence of exclusion criteria
– Physician reluctance to administer the drug due to
inexperience, unavailability of neurological
consultation, or fear of medical complications or legal
ramifications
s
#1 Reason for IV TPA exclusion:
Delay to ER
73%
Only 27% of those presenting within 3 hours
were treated with IV TPA
Of those presenting <3 hours (n=314):
1. Rapid improvement
2. Mild symptoms
3. Protocol exclusion
4. Delay in ER
5. Comorbidity
Barber PA, et al. Neurology 2001;56:1015-1020.
18%
13%
14%
9%
8%
s
Recommendations for appropriate use of tissue
plasminogen activator
Key elements
– Acute stroke teams
– Written care protocols
– Integrated emergency response
system and infrastructure for
hyperacute evaluation
– Documentation checklist
– Quality improvement programs
JAMA, June 21, 2000-Vol 283, No. 23
s
Acute Stroke Team
• Dedicated pager: “Stroke Code”
• Arrival at bedside within 15 minutes
• Protocols/standing orders in place for all stroke patients:
– Written stroke protocols for IV tPA associated with fewer
complications
– Post treatment care pathways (BP control after tPA)
• Stroke team members
–
–
–
–
–
–
Stroke neurologist
Emergency room physician
Residents (if applicable)
Nurses
Radiologist and technicians
Pharmacist
s
Hospital Logistics
• Neuroradiology
– CT available 24 hours a day
– Completed within 25 minutes
– Read within 45 minutes
• Laboratory services
– Results of CBC, BMP, coags back within 45 minutes
•
•
•
•
Family, patient, staff, and EMS education
Data collection and performance improvement
Community outreach and education
Institutional support and leadership
s
Acute Stroke Pager
NOTICE: CHANGE IN THE
NEUROLOGY PAGER*
85-7800 is the new pager for Neurology
Use this pager to reach neurology for
consults (routine and urgent), for
questions to neurology, etc…
85-4500 is now the Acute Stroke Pager
Use this pager for suspected acute
stroke (i.e. stroke onset < 12 hours)
Use of this pager will activate the acute
stroke team
*These changes will be effective on January 2, 2007
RUMC ALGORITHM ACUTE STROKE (ED)
Clinical Suspicion of ACUTE STROKE < 12 Hours from onset
s
a) New neurological deficit (weakness, numbness, change in
vision, change in speech, clumsiness, trouble walking)
OR
b) Acute decrease in level of consciousness
OR
c) Worst headache of life
Emergency Department
Activate Acute Stroke Pager (85-4500)
Notify ED attending
Vital signs and finger stick
Place 2 large bore peripheral IV’s, NPO
Labs (with special label):
- CBC, PT/PTT,
- Chem7, troponin
- Type & hold
Urine HCG (pre-menopausal women)
Notify Radiology technician (26874)
STAT Head CT (done w/i 25 min)
Neurologic exam/determine onset time
Obtain 12-lead ECG, pulse ox
Give supplemental O2 for Sp02<93%
Obtain chest X-Ray STAT
Alert pharmacy if tPA eligible
Acute Stroke Team
At bedside within 15 minutes of page.
Confirm time of onset (last known normal)
Obtain Past Med Hx
- Prior ICH or SAH
- Known cerebral AVM, aneurysm, tumor
- Recent trauma or surgery
- Review current medications
Check vital signs (review BP)
Perform NIHSS
Review Head CT (read by 45 minutes of arrival)
Review available lab tests (gluc, plts, coags)
Discuss with Stroke Attending
INITIATE TREATMENT
s
Stroke Labs
s
Acute stroke labs and CT compliance
Percentage
100
CT protocol
change
2/1/07
Stroke lab
protocol
change
3/17/07
Feb
Mar
80
60
40
20
0
Jan
Apr
May
Jun
Month
Labs under 45 minutes
CT under 25 minutes
Jul
s
s
s
Assess Stroke Treatment Rates
Analyze Process from ED to
Discharge, Rates of TPA Use, Other
Standards of Care
Implement Refined Protocol
Evaluate Assessment
Coordinate Implementation of
Refined Protocol
Review Summary
Reports
Refine Protocol
Identify
Areas for Improvement
s
• Goal door-to-treatment time < 60 minutes and
reduce treatment-related complications
• Continue to review outcomes following acute
stroke interventions
– Monthly meetings
– Continue to improve CT and lab times
– Chart review for protocol violations and
documentation errors
• Re-educate staff members on protocols
– Emails
– Staff meeting presentations
– In-services
– Stroke champion