Transcript Thrombolysis

Scottish Hyperacute stroke Activity
Register and Evaluation (SHARE)
Peter Langhorne
University of Glasgow
What’s in a name?
S – Scottish
H - Hyperacute
A – Assessment and
M - Management
E - Evaluation
What’s in a name?
S – Scottish
H - Hyperacute
I - Investigation and
T - Treatment
E - Evaluation
What’s in a name?
S – Scottish
H – Hyperacute stroke
A – Activity
R – Register and
E - Evaluation
Stroke in Scotland
• Over 10,000 people have a
new stroke each year
• 70,000 Scots living with
consequences of a stroke
• Average lifetime cost of
stroke £45,000
• Good progress in
developing services
• SSCA has help drive up
standards
Thrombolysis in acute stroke
Before
After
In 2002, European Union regulatory authority
approved rt-PA for stroke CONDITIONALLY
• Within 3 hours of an
ischaemic stroke
• Age 18-80
• In high quality stroke centres with
stroke units with certain monitoring
requirements
Time is Brain
Impact of thrombolysis
Number making full recovery per 100 treated
30
Benefit
20
10
0
0
2
4
6
Time (hours)
Saver, Stroke 2006
Haemorrhage into an infarct
Time is Brain
Impact of thrombolysis
Number making full recovery per 100 treated
30
Benefit
20
10
Harm
0
0
2
4
6
Time (hours)
Saver, Stroke 2006
Inclusion criteria
• Clinical symptoms and signs of definite acute
stroke
• Clear time of onset
• Presentation within 3 hrs of acute onset
• Haemorrhage excluded by CT scan
• Age 18 - 80 years old
• NIHSS less than 25
• Consent to treat (every effort must be made to
contact next of kin)
Exclusion criteria
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Rapidly improving or minor stroke symptoms
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Stroke or serious head injury 3 months
Major surgery, obstetrical delivery, external heart
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massage last 14 days,
Seizure at onset of stroke
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Prior stroke and concomitant diabetes
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Severe haemorrhage last 21/7
Increase bleeding risk
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History of central nervous damage (neoplasm,
haemorrhage, aneurysm, spinal or intracranial surgery or
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haemorrhagic retinopathy)
Symptoms suggestive of SAH (even if CT is normal)
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*Blood pressure above 185 mmHg systolic or 110
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mmHg diastolic
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Known clotting disorder
Patient on heparin or warfarin
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Suspected iron deficient anaemia or thrombocytopenia
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Suspected hypoglycaemia or hyper glycaemia >3
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mmol/l > 22 mmol/l
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Bacterial endocarditis, pericarditis
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Acute pancreatitis
Premorbid dependency
Ulcerative GI disease last 3 months, oesophageal
varices, arterial-aneurysm, arterial/venous
malformation.
Severe liver disease including cirrhosis, acute
hepatitis
Neoplasm with increased bleeding risk
Large hypodensity on CT scan (use ASPECTS*
scoring if time permits; otherwise use the 1/3 of
MCA territory rule)
Symptoms suggestive of SAH (even if CT is
normal)
*Blood pressure above 185 mmHg systolic or 110
mmHg diastolic
Known clotting disorder
Patient on heparin or warfarin
Suspected iron deficient anaemia or
thrombocytopenia
Suspected hypoglycaemia or hyper glycaemia >3
mmol/l > 22 mmol/l
Bacterial endocarditis, pericarditis
Acute pancreatitis
Premorbid dependency
Ulcerative GI disease last 3 months, oesophageal
varices, arterial-aneurysm, arterial/venous
malformation.
Low density
loss of grey/white definition
loss of insula
loss of basal ganglia
Hyperdense artery
Swelling
loss of sulci
effacement of ventricles
Farrall, Kane, Wardlaw
Conditions
• Acute stroke unit
• Under the care of stroke physician or
neurologist
• Monitored bed
• Nurses trained in thrombolysis & acute
skills
• Protocols & guidelines for care
• Access to immediate imaging (24hrs)
CT head scanning availability
Hyperacute stroke specialist teams
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Patient has Video Consultation with the
consultant following viewing of CT brain image
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Network of acute sites (with CT scanning) and
stroke specialists
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rt-PA for stroke per million pop'n
Use of rt-PA for acute ischaemic stroke ‘within
licence’ in Europe (SITS-MOST registry 2007)
250
200
150
100
50
0
Finland
Sweden
Austria
Norway
Czech Republic
Slovenia
Belgium
Denmark
Spain
Iceland
Germany
Portugal
Italy
Slovakia
Australia
Netherlands
United Kingdom
Lithuania
Poland
France
Greece
Croatia
Hungary
Russia
SITS-MOST 29/1/2007
SITS Register
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Section
Data itemBaselineTreatment file namePostcodeCHI
numberAgeGenderSITS-MOST patientDate/time
stroke onsetDate/time arrival 1st hospitalDate/time
arrival Rx hospitalDate/time brain imaging
examDate/time brain imaging reportDate/time of rtPA treatmentRankin before
strokeHypertensionDiabetesHyperlipidaemiaCurrent
smokerPrevious smokerPrevious diagnosis of
strokeAtrial fib (incl. Paroxysmal)Congestive heart
failureNumber of risk factorsAspirin at stroke
onsetDipyridamole at stroke onsetClopidogrel at
stroke onsetOther antiplatelet at stroke
onsetAnticoagulants, high doseAnticoagulants, low
doseAnticoagulants, oralAntihypertensive at stroke
onsetAntihypertensive oralGlucose before
treatmentTotal serum cholesterol level within 24h of
stroke onsetCurrently partic. In stroke RCTMethod
of consultation [a]Brain imaging review
[b]ADRCause of ADR is reasonable related to
Actilyse treatmentType of ADRDate SADR faxed to
BIIntensity of ADRDate/time of onset of
ADRSpecify reaction [c]Treatment file nameSITSMOST patientAgeGenderCause of ADR is
reasonable related to Actilyse treatmentType of
ADRDate SADR faxed to BIIntensity of
ADRCriteria of serious ADRDate/time of onset of
ADRSpecify reactionSerious AD report form
DeathTreatment file nameSITS-MOST patientAgeGenderDate
of deathPrimary cause of deathCause of death reasonable
related to Actilyse treatmentAdd. info. related to deathSerious
AD report formNIH stroke scale - BeforeNIH done – before
treatmentIf NIH done – total scoreSystolic BPDiastolic BPNIH
items 1-11NIH total (calculated)NIH stroke scale – At 2hNIH
done – at 2hSystolic BPDiastolic BPNIH items 1-11NIH total
(calculated)NIH stroke scale – At 24hNIH done – at
24hSystolic BPDiastolic BPNIH items 1-11NIH total
(calculated)NIH stroke scale – At 7dNIH done – at 7dSystolic
BPDiastolic BPNIH items 1-11NIH total
(calculated)ImagingCT doneCT date/timeCT current infarctCT
dense artery signCTA occlusion (optional)CT perfusion deficit
(optional)CT perfusion deficit volume optCT infarct volume
(optional)CT perfusion/infarct mismatch (optional)CT local
haemorrhageCT remote haemorrhageCT volume PH2CT
cerebral oedemaMR doneMR date/timeMR current infarctMR
artery occlusionMR perfusion deficit (optional)MR diffusion
volume (optional)MR perfusion/infarct mismatch (optional)MR
local haemorrhageMR remote haemorrhageMR volume
PH2MR cerebral oedemaBrain Imaging result [d]TCD
occlusionTCD date/timeTreatmentTreatment file nameSITSMOST patientAgeGenderHas patient received treatment with
ActilyseDose mgEstimated weight (kilos)Measured weight
(kilos)Reason why no treatment was given [e]Full dose given
(0.9mg/kg)Reason why full dose was not given24hTreatment
file nameSITS-MOST patientAgeGenderGlobal outcome 24h
after start of rt-PA treatment [f]DischargeTreatment file
nameSITS-MOST patientAgeGenderAspirin since
admissionDipyridamol since admissionClopidogrel since
admissionOther antiplatelet since admissionAnticoagulants,
high doseAnticoagulants, low doseAnticoagulants,
oralAntihypertensive, ivAntihypertensive, oralI-national class
of diseases(ICD)Repeat brain imaging done [g]Repeat brain
imaging result [h]Global outcome on discharge /7dGlobal
outcome on discharge /7d [i] ?Total serum cholesterol level at 7
days of stroke onset, mg/dl3 month follow upTreatment file
nameSITS-MOST patientAgeGenderRankin 3m months (+/- 10
days)
SHARE project
Prospective part
Retrospective part
• Basic common dataset in
SSCA
• Numbers treated
• Contraindications
• Time to treatment
• Complications
• Outcomes
• Equity/service issues
• Jan 2008 – present
• Multiple local audits
• Compile basic common
dataset
• Same data as SSCA
• Same outcomes and
analysis
• Centralised resource
SHARE project
Prospective part
Retrospective part
• Basic common dataset in
SSCA
• Numbers treated
• Contraindications
• Time to treatment
• Complications
• Outcomes
• Equity/service issues
• Jan 2008 – present
• Multiple local audits
• Compile basic common
dataset
• Same data as SSCA
• Same outcomes and
analysis
• Centralised resource
Section
Data item
Patient details
Date/time arrival at treating hospital
Details
Date/time brain imaging exam
Date/time of rt-PA treatment
Process
If not given, reason why no treatment was
given
Too late, medical contraindication,
radiological contraindication, other.
Method of consultant consultation
Face-to-face, videoconference, telephone,
other
Brain imaging review
Stroke consultant, radiologist, other
Brain Imaging result
NIH stroke scale
NIH done – before treatment
If NIH done – total score
NIHSS
Repeat brain imaging done
yes/ no
Discharge
Repeat imaging
Date of repeat imaging
Adverse reaction
(ADR)
Repeat brain imaging result
normal, infarct, haemorrhage, other
ADR occurred - reasonably related to Actilyse
treatment
Anaphylaxis, symptomatic intracranial
haemorrhage, other haemorrhage, other
Date of ADR
Outcome
Function
Rankin score
3 Month
Function
Rankin score (optional?)
The promise and challenge of
thrombolysis for ischaemic stroke
• Promising treatment for a minority of stroke
patients
• National and international guidelines NICE
technology appraisal
• Features in Scottish and English stroke strategies
• Challenge to deliver in practical and equitable
manner
• Need to monitor developments in Scotland